BROAD SPECTRUM SPF 30 FOR FACE AND BODY- zinc oxide cream

Broad Spectrum SPF 30 for Face and Body by

Drug Labeling and Warnings

Broad Spectrum SPF 30 for Face and Body by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Zinc Oxide - 18.6%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

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

Warnings: For external use only.

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other Information High sun protection product.

QUESTIONS

Call toll free 1-800-798-7970

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

Made in USA

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

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