PROTECT BROAD SPECTRUM SPF 30- zinc oxide cream

Protect Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Protect Broad Spectrum SPF 30 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 Ingredient:

Zinc Oxide - 18.9%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

Warnings: For external use only.

DO NOT USE

Do not use on damaged or broken skin.

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 occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children if product is swallowed, get medical help or contact a Poison Control right away.

DOSAGE & ADMINISTRATION

Directions:

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply: after 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 10am - 2pm.
• wear long sleeves shirts, pants, hats and sunglasses.
• Children under 6 months: Ask a doctor.         

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS

Email; info@aoskincare.com or call (415)653-3939

INACTIVE INGREDIENT

Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearic Acid, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isosrearic Acid, Lecithin, Cetyl Alcohol, Lanolin, Aloe Barbadensis Leaf Juice, Phomium Tenax Seed Oil, Stearyl Alcohol, Gardenia Jasminoides Meristem Cell Culture, Niacinamide, Prunus Amygdulus Dulcis (Sweet Almond) Oil, Honey, Tocopherol, Totarol, Ferulic Acid, Disodium EDTA, Xanthan Gum, Carageenan, Punica Granatum Extract, Dihydroacetic Acid, Corn Starch Modified, Benzyl Alcohol, Astaxanthin.

PRINCIPAL DISPLAY PANEL

Distributed by Distil Skincare LLC

Mailing address: Swapbox ATUP1-1T5DK,

880 Peru Ave #2, San Francisco 94112, USA

INGREDIENTS AND APPEARANCE

PROTECT BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	189 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALOE (UNII: V5VD430YW9)
PHORMIUM TENAX SEED OIL (UNII: OZ80CEA779)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GARDENIA CORNUTA WHOLE (UNII: 0WC27VVS87)
NIACINAMIDE (UNII: 25X51I8RD4)
PRUNUS AMERICANA FRUIT (UNII: 3F57WKW68K)
HONEY (UNII: Y9H1V576FH)
TOCOPHEROL (UNII: R0ZB2556P8)
TOTAROL (UNII: 67NH2854WW)
FERULIC ACID (UNII: AVM951ZWST)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
CARRAGEENAN (UNII: 5C69YCD2YJ)
PUNICA GRANATUM FLOWER (UNII: D9B634V4GP)
CORN STARCH 3-E-DODECENYL SUCCINIC ANHYDRIDE MODIFIED (UNII: QG4MW19XYX)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ASTAXANTHIN (UNII: 8XPW32PR7I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4166-2	1 in 1 CARTON	02/09/2018
1	NDC: 62742-4166-1	59 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/09/2018

Labeler - Allure Labs Inc (926831603)