Label: SCRUBS SUNSCREEN- sunscreen lotion
- NDC Code(s): 51239-2921-0
- Packager: ITW Pro Brands
- 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 January 10, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- USAGE
- WARNING
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DIRECTIONS
Directions
-apply liberally (or generously) and evenly 15 minutes before sun exposure.
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 sum, especially from 10 a.m. – 2 p.m.
-wear long-sleeved shirts, pants, hats, and sunglasses
reapply:
-after 80 minutes of swimming or sweating.
-immmediatly after towel drying.
-at least every 2 hours.
Children under 6 months of age: Ask a doctor.
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INACTIVE INGREDIENTS
Acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, butylparaben, carbomer, calendula officinalis flower extract, chamomile recutita (matricaria) extract, C12-15 alkyl benzoate, dimethicone, dimethyl capramide, ethylparaben, fragrance (parfum), glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale (watercress) extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale (comfrey) leaf extract, tetrasodium EDTA, tocopherol, tocopheryl acetate, triethanolamine, water.
- STORAGE AND HANDLING
- ASK A DOCTOR
- KEEP OUT OF THE REACH OF CHILDREN
- PURPOSE
- PACKAGE LABEL
-
INGREDIENTS AND APPEARANCE
SCRUBS SUNSCREEN
sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51239-2921 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.05 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.06 g in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.05 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE SODIUM (UNII: MP1J8420LU) WATER (UNII: 059QF0KO0R) SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) BUTYLPARABEN (UNII: 3QPI1U3FV8) DIMETHICONE 200 (UNII: RGS4T2AS00) PEG-100 STEARATE (UNII: YD01N1999R) TOCOPHEROL (UNII: R0ZB2556P8) C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) WATERCRESS (UNII: K5877MW0LE) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CHAMOMILE (UNII: FGL3685T2X) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51239-2921-0 7 g in 1 POUCH; Type 0: Not a Combination Product 05/01/2017 12/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2017 12/01/2024 Labeler - ITW Pro Brands (067952994) Establishment Name Address ID/FEI Business Operations CoreTex Products 061944620 pack(51239-2921)
