Drug Facts

Active Ingredients: Zinc Oxide - 18.6%

Purpose: Sunscreen

Uses:

Provided high protection against sunburn.
Broad Spectrum (UVA and UVB) protection.
If used with directed with other sun protection measures,decreases the risk of skin cancer and early skin aging caused by sun.

Warnings: For external use only.

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

Stop use and ask a doctor if rash or irritation occurs.

Keep out of reach of children.

Directions:

Apply generously 15 minutes before su exposure.
Reapply at least every 2 hours. After swimming or sweating. Immediately after towel drying.
Children under 6 months of age: ask a doctor.

Other Information High sun protection product.

Call toll free 1-800-798-7970

Water (Aqua), Cyclopentasiloxane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Polyacrylamide, C13-14 Isoparaffin, Lecithine, Imperata Cylindrica Root Extract, Xanthan Gum, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Carbomer, PEG-8, Disodium EDTA.

Made in USA

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

SPF 30 Face Body 24

BROAD SPECTRUM SPF 30 FOR FACE AND BODY
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62742-4116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	186 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
LAURETH-7 (UNII: Z95S6G8201)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62742-4116-1	68 g in 1 TUBE; Type 0: Not a Combination Product	12/04/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/04/2017

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Name	Address	ID/FEI	Business Operations
Establishment
Allure Labs Inc		926831603	manufacture(62742-4116)