Label: PROTECT BROAD SPECTRUM SPF 30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4166-1, 62742-4166-2 - Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 9, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
- QUESTIONS
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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
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INGREDIENTS AND APPEARANCE
PROTECT BROAD SPECTRUM SPF 30
zinc oxide creamProduct 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)
