Label: NO7 PROTECT AND PERFECT DAY SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68472-109-01 - Packager: Boots Retail USA Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 1, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS AND PRECAUTIONS
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directons
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Chidren under 6 months of age: Ask a doctor
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 value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10a,m - 2p.m
wear long-sleeved shirts, pants, hat and sunglasses
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients
Aqua (water), Glycerin, C12-15 alkyl benzoate, Butyrospermum parkii (shea) butter, Dimethicone, Isononyl isonanoate, Cetearyl alcohol, C18-36 acid glycol ester, Polyglyceryl-3-methylglucose distearate, Phenoxyethanol, Polyacrylamide, Sorbitan stearate, Mica, Polysorbate 20, Alcohol denat., Methylparaben, Potassium cetyl phosphate, Ethylparaben, Parfum (fragrance), Laureth-7, Retinyl palmitate, Sucrose cocoate, Dipropylene glycol, Xanthan gum, ascorbyl glucoside, Tetrasodium EDTA, Citric acid, Lupinus albus seed extract, Dimethylmethoxy chromanol, Carbomer, Phyllanthus emblica fruit extract, Potassium hydroxide, Ginkgo biloba leaf extract, BHT, Tocopherol, Butylparaben, Palmitoyl oligopeptide, Propylparaben, Isobutylparaben, Palmitoyl tetrapeptide-7, CI 77891 (Titanium dioxide)
- QUESTIONS
- DESCRIPTION
- INFORMATION FOR PATIENTS
- DESCRIPTION
- ACTIVE INGREDIENT
- WARNINGS
- INDICATIONS & USAGE
- INFORMATION FOR PATIENTS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NO7 PROTECT AND PERFECT DAY SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68472-109 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 1.5 mL in 50 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 3 mL in 50 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 1.25 mL in 50 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SHEA BUTTER (UNII: K49155WL9Y) Dimethicone (UNII: 92RU3N3Y1O) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) mica (UNII: V8A1AW0880) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALCOHOL (UNII: 3K9958V90M) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ETHYLPARABEN (UNII: 14255EXE39) LAURETH-7 (UNII: Z95S6G8201) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SUCROSE COCOATE (UNII: 3H18P0UK73) DIPROPYLENE GLYCOL (UNII: E107L85C40) XANTHAN GUM (UNII: TTV12P4NEE) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) EDETATE SODIUM (UNII: MP1J8420LU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LUPINUS ALBUS SEED (UNII: 24GB753W3B) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) GINKGO (UNII: 19FUJ2C58T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLPARABEN (UNII: 3QPI1U3FV8) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68472-109-01 1 in 1 CARTON 1 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2012 Labeler - Boots Retail USA Inc (143151533) Registrant - The Boots Company PLC (218622660) Establishment Name Address ID/FEI Business Operations BCM Ltd 230780322 manufacture, analysis