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NDC 69435-1505-01 SUN and SHINE MINERAL SUNSCREEN 24.5 g/100mL Details

SUN and SHINE MINERAL SUNSCREEN 24.5 g/100mL

SUN and SHINE MINERAL SUNSCREEN is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Peer Pharm Ltd.. The primary component is ZINC OXIDE.

Product Information

NDC	69435-1505
Product ID	69435-1505_e881ae75-ba6e-3eab-e053-2995a90af844
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	SUN and SHINE MINERAL SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	24.5
Active Ingredient Units	g/100mL
Substance Name	ZINC OXIDE
Labeler Name	Peer Pharm Ltd.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69435-1505-01 (69435150501)

Pricing Information	N/A
NDC Package Code	69435-1505-1
Billing NDC	69435150501
Package	1 TUBE in 1 CARTON (69435-1505-1) / 50 mL in 1 TUBE
Marketing Start Date	2022-05-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 897eb75c-d7d6-4fce-afdd-f794fd8a82fd Details

Drug Facts

Active Ingredients

Zinc Oxide 24.5%

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 or irritation develops and lasts.

Keep out of reach of children.

If swallowed, call a poison control center or get medical help right away.

Directions

Apply liberally 15 minutes before sun exposure

• Reapply:

• after 40 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 am to 2 p.m.

• wear long-sleeve shirts, pants, hats, and sunglasses

• Children under 6 months: ask a doctor

Other information

protect this product from excessive heat and sun

Inactive Ingredients

aqua, coco-caprylate, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, cetearyl olivate, sorbitan olivate, caprylyl glycol, glycerin, polyhydroxystearic acid, aloe barbadensis leaf juice, panthenol, triethoxycaprylylsilane, cetearyl alcohol, tocopherol, butyrospermum parkii (shea) butter, silica, silica dimethyl silylate, xanthan gum, caprylhydroxamic acid, propanediol, sodium phytate, dipotassium glycyrrhizate, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, citric acid

Questions or Comments

Call 951-297-7976 or visit www.kcare.co.il

Product label

INGREDIENTS AND APPEARANCE

SUN AND SHINE MINERAL SUNSCREEN

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69435-1505
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TOCOPHEROL (UNII: R0ZB2556P8)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE (UNII: 4828G836N6)
SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L)
ISOBUTANE (UNII: BXR49TP611)
WATER (UNII: 059QF0KO0R)
1-(ETHYLTRISULFANYL)PROPANE (UNII: 4SOS6O9G2X)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL 1-PHOSPHATE (UNII: 48G71659RB)
CHAMOMILE (UNII: FGL3685T2X)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE (UNII: V5VD430YW9)
1,4-BUTANEDITHIOL (UNII: 7JD227IUMC)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69435-1505-1	1 in 1 CARTON	05/19/2022
1		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
OTC monograph not final	part352	05/19/2022

Labeler - Peer Pharm Ltd. (514678390)

Registrant - Peer Pharm Ltd. (514678390)

Name	Address	ID/FEI	Business Operations
Establishment
Peer Pharm Ltd.		514678390	manufacture(69435-1505)

Revised: 9/2022

Document Id: e881ae75-ba6e-3eab-e053-2995a90af844

Set id: 897eb75c-d7d6-4fce-afdd-f794fd8a82fd

Version: 1

Effective Time: 20220912