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NDC 73509-0050-02 by Selected Daily Broad Spectrum Sunscreen 3.5; 2 g/50mL; g/50mL Details

by Selected Daily Broad Spectrum Sunscreen 3.5; 2 g/50mL; g/50mL

by Selected Daily Broad Spectrum Sunscreen is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Garam Of Nature. The primary component is OCTINOXATE; OCTISALATE.

Product Information

NDC	73509-0050
Product ID	73509-050_4583c1dc-5c2d-4794-bce0-75962fdd4a9b
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	by Selected Daily Broad Spectrum Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	3.5; 2
Active Ingredient Units	g/50mL; g/50mL
Substance Name	OCTINOXATE; OCTISALATE
Labeler Name	Garam Of Nature
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73509-0050-02 (73509005002)

Pricing Information	N/A
NDC Package Code	73509-050-02
Billing NDC	73509005002
Package	1 TUBE in 1 CARTON (73509-050-02) / 50 mL in 1 TUBE (73509-050-01)
Marketing Start Date	2021-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d218a8de-e996-4e5e-a931-b29017909b78 Details

ACTIVE INGREDIENTS

Ethylhexyl Methoxycinnamate 7.0%

Ethylhexyl Salicylate 4.0%

INACTIVE INGREDIENTS

Water, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dipropylene Glycol, Butylene Glycol, Ethylhexyl Palmitate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Dibutyl Adipate, Ethylhexyl Triazone, Glyceryl Stearate, Hexyl Laurate, olyglyceryl-3 Methylglucose Distearate, Polysorbate 60, C14-22 Alcohols, PEG-100 Stearate, 1,2-Hexanediol, Limonia Acidissima Extract, Hydroxyacetophenone, Silica, Fragrance, C12-20 Alkyl Glucoside, Carbomer, Dimethicone, Tromethamine, Ophiopogon Japonicus Root Extract, Panax Ginseng Root Extract, Schisandra Chinensis Fruit Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Disodium EDTA,

Ipomoea Purpurea Extract, Lilium Candidum Flower Extract, Magnolia Liliflora Flower Extract, Paeonia Albiflora Flower Extract

PURPOSE

Sunscreen

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 product is swallowed, get medical help or contact a Posion Control Center right away

KEEP OUT OF REACH OF CHILDREN

If product is swallowed, get medical help or contact a Posion Control Center right away

Uses

■ helps prevent sunburn

■ it used as directed with other sun protection measures (see Directions). Decreases the risk of skin cancer and early skin aging caused by the sun

Directions

■ Apply liberally and spread evenly by hand 15 minutes before sun exposure•reapply:•after 80 minutes of swimming or sweating•immediately after towel drying • at least every 2 hours•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 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-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a docto

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Questions

www.byselected.co.kr

[email protected]

+82-70-8883-2525

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BY SELECTED DAILY BROAD SPECTRUM SUNSCREEN

ethylhexyl methoxycinnamate, ethylhexyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73509-050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73509-050-02	1 in 1 CARTON	07/01/2021
1	NDC:73509-050-01	50 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
unapproved drug other		07/01/2021

Labeler - Garam Of Nature (695640134)

Registrant - Garam Of Nature (695640134)

Name	Address	ID/FEI	Business Operations
Establishment
Garam Of Nature		695640134	manufacture(73509-050)

Revised: 8/2021

Document Id: 4583c1dc-5c2d-4794-bce0-75962fdd4a9b

Set id: d218a8de-e996-4e5e-a931-b29017909b78

Version: 1

Effective Time: 20210803