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NDC 59062-5200-01 outdoor adventure set Details

outdoor adventure set

outdoor adventure set is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by KAS Direct LLC dba BabyGanics. The primary component is .

Product Information

NDC	59062-5200
Product ID	59062-5200_7f16e117-310e-418d-84c9-c2344b3532e9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	outdoor adventure set
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide, Titanium Dioxide, and Octisalate
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	KAS Direct LLC dba BabyGanics
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 59062-5200-01 (59062520001)

Pricing Information	N/A
NDC Package Code	59062-5200-1
Billing NDC	59062520001
Package	1 KIT in 1 PACKAGE (59062-5200-1) * 59 mL in 1 TUBE (59062-1100-2) * 142 g in 1 CAN
Marketing Start Date	2019-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8f0f2707-7fd6-491d-a928-7d420b17da80 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octisalate 5.0%, Titanium Dioxide 3.0%, Zinc Oxide 6.0%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
children under 6 months of age: ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

water, butyloctyl salicylate, neopentyl glycol diethylhexanoate, caprylic/capric triglyceride, stearyl/octyldodecyl citrate crosspolymer, polyglyceryl-2 stearate, simmondsia chinensis (jojoba) seed oil1, hydrogenated dimer dilinoleyl/dimethylcarbonate copolymer, glyceryl stearate, cetyl alcohol, cocos nucifera (coconut) oil1, glycerin1, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, butyrospermum parkii (shea) butter1, jojoba esters, stearyl alcohol, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, polyhydroxystearic acid, xanthan gum, silica, alumina, ethylhexylglycerin, trisodium ethylenediamine disuccinate, phenoxyethanol

1: Certified Organic Ingredient

Unless otherwise specified, product not labeled as organic

SPL UNCLASSIFIED SECTION

dist. by KAS Direct, LLC.

637 Commercial Street, Suite 300

San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - Kit Package

babyganics

outdoor

adventure set

mosquito bites?

sun burns? we've

got you covered

Discover which of our

ingredients are Certified

Organic on back panel.

natural insect

repellent

5 FL OZ (142 g)

SPF 50+

sunscreen lotion

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

OUTDOOR ADVENTURE SET

zinc oxide, titanium dioxide, and octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59062-5200

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59062-5200-1	1 in 1 PACKAGE; Type 0: Not a Combination Product	01/01/2019

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	59 mL
Part 2	1 CAN	142 g

Part 1 of 2
KIDS SPF 50 PLUS SUNSCREEN titanium dioxide, octisalate, and zinc oxide lotion

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	30 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Stearyl/Octyldodecyl Citrate Crosspolymer (UNII: PN88NW0KPK)
Polyglyceryl-2 Stearate (UNII: 253MC0P0YV)
CETYL ALCOHOL (UNII: 936JST6JCN)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
TOMATO SEED OIL (UNII: 7N87T9C06T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
Nigella Sativa Seed Oil (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
DOCOSANOL (UNII: 9G1OE216XY)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59062-1100-2	59 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/24/2017

Part 2 of 2
NATURAL INSECT REPELLENT lotions, oils, powders, and creams spray

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	soybean oil (UNII: 241ATL177A)
INGR	rosemary oil (UNII: 8LGU7VM393)
INGR	Citronella Oil (UNII: QYO8Q067D0)
INGR	GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
INGR	JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
INGR	Peppermint Oil (UNII: AV092KU4JH)
INGR	WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		142 g in 1 CAN; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Cosmetic		01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2019

Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 11/2020

Document Id: 7f16e117-310e-418d-84c9-c2344b3532e9

Set id: 8f0f2707-7fd6-491d-a928-7d420b17da80

Version: 1

Effective Time: 20201123

Search by Drug Name or NDC

NDC 59062-5200-01 outdoor adventure set Details

outdoor adventure set

Product Information

Package

Package Images

NDC 59062-5200-01 (59062520001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 8f0f2707-7fd6-491d-a928-7d420b17da80 Details

SPL UNCLASSIFIED SECTION

Active ingredients

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - Kit Package

INGREDIENTS AND APPEARANCE

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