Label: NO7 RESTORE AND RENEW FACE AND NECK MULTI ACTION DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, octocrylene, octisalate cream
- NDC Code(s): 11489-175-01
- Packager: BCM Ltd
- 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 22, 2020
If you are a consumer or patient please visit this version.
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Directions
Directions
apply liberally 15 minutes before sun exposure.
reapply at least every 2 hours.
use a water resistant sunscreen if swimming or sweating.
children 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 10 a.m - 2 p.m.
wear long-sleeved shirts,pants,hats and sunglasses
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Inactive ingredients
Aqua (Water), C12-15 alkyl benzoate, Glycerin, Alcohol denat., Tribehenin, Aluminum starch octenylsuccinate, Butylene glycol, Dimethicone, Cetearyl alcohol, Cetearyl glucoside, Butyrospermum parkii (Shea) butter, Ammonium acryloydimethyltaurate/VP copolymer, Silica, Phenoxyethanol, Potassium cetyl phosphate, Methylparaben, Tocopheryl acetate, Dimethiconol, Pentylene glycol, Ascorbyl glucoside, Parfum (Fragrance), Propylene glycol, Xanthan gum, Ethylparaben, Hibiscus abelmoschus extract, Retinyl palmitate, Simethicone, Hydrolyzed hyaluronic acid, Dipropylene glycol, Hydrolyzed rice protein, Tetrasodium EDTA, Sorbitan laurate, Polysorbate 20, T-butyl alcohol, Sodium lauroyl lactylate, Phyllanthus emblica fruit extract, Carbomer, Calcium hydroxymethionine, Panax ginseng root extract, 3-aminopropane sulfonic acid, Hydroxyethylcellulose, Potassium hydroxide, Dimethylmethoxy chromanol, Acetyl dipeptide-1 cetyl ester, Morus alba leaf extract, Ceramide 3, Ceramide 6 II, Sodium benzoate, Phytosphingsine, Cholesterol, Ethylhexylglycerin, Tocopherol, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7, Ceramide 1, CI 77891 (Titanium dioxide), CI 77491 (Iron oxides), CI 14700 (Red 4).
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INGREDIENTS AND APPEARANCE
NO7 RESTORE AND RENEW FACE AND NECK MULTI ACTION DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, octocrylene, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11489-175 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.75 g in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.00 g in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.25 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) DIMETHICONE (UNII: 92RU3N3Y1O) TRIBEHENIN (UNII: 8OC9U7TQZ0) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) XANTHAN GUM (UNII: TTV12P4NEE) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) EDETATE SODIUM (UNII: MP1J8420LU) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) MORUS ALBA LEAF (UNII: M8YIA49Q2P) CERAMIDE 3 (UNII: 4370DF050B) SODIUM BENZOATE (UNII: OJ245FE5EU) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CERAMIDE 6 II (UNII: F1X8L2B00J) CHOLESTEROL (UNII: 97C5T2UQ7J) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TOCOPHEROL (UNII: R0ZB2556P8) CERAMIDE 1 (UNII: 5THT33P7X7) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BROWN IRON OXIDE (UNII: 1N032N7MFO) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ASIAN GINSENG (UNII: CUQ3A77YXI) ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR) ALCOHOL (UNII: 3K9958V90M) SILICON (UNII: Z4152N8IUI) ABELMOSCHUS MOSCHATUS WHOLE (UNII: M7QAW6696G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11489-175-01 1 in 1 CARTON 06/22/2020 1 25 g 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 not final part352 06/22/2020 Labeler - BCM Ltd (230780322) Registrant - The Boots Company PLC (218622660) Establishment Name Address ID/FEI Business Operations BCM Ltd 230780322 manufacture(11489-175) , analysis(11489-175)