Label: FRUIT OF THE EARTH BLOCK UP KIDS SPF 50 MOISTURIZING SUNSCREEN- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 62217-013-11, 62217-013-15
- Packager: Fruit of the Earth, 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 May 23, 2017
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of 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 10 a.m. - 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • children under 6 months: ask a doctor
- Other information
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Inactive ingredients
water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, propylene glycol, dicetyl phosphate, ceteth-10 phosphate, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), sodium ascorbyl phosphate (vitamin C), calendula officinalis flower extract, symphytum officinale rhizome/root extract, arctium lappa root extract, hydrastis canadensis (golden seal) root extract, honey extract, anthemis nobilis flower extract, tilia cordata flower extract, hydrated silica, potassium cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben, isobutylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, disodium EDTA
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- Fruit of the Earth Block Up! Kids SPF 50 Moisturizing Sunscreen Lotion
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH BLOCK UP KIDS SPF 50 MOISTURIZING SUNSCREEN
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 90 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) ALOE VERA LEAF (UNII: ZY81Z83H0X) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) HYDRATED SILICA (UNII: Y6O7T4G8P9) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) TROLAMINE (UNII: 9O3K93S3TK) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) METHYLPARABEN (UNII: A2I8C7HI9T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLPARABEN (UNII: 3QPI1U3FV8) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) HONEY (UNII: Y9H1V576FH) GOLDENSEAL (UNII: ZW3Z11D0JV) TILIA CORDATA WHOLE (UNII: W5E5UB44GD) COMFREY ROOT (UNII: M9VVZ08EKQ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-013-15 177 mL in 1 TUBE; Type 0: Not a Combination Product 05/23/2017 2 NDC:62217-013-11 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/23/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/23/2017 Labeler - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(62217-013)
