Label: FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM BABY SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 62217-174-05
- 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 December 20, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use on
- When using this product
- Stop use and ask doctor
- Keep out of reach of children.
-
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 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
- children under 6 months: Ask a doctor
-
Inactive ingredients
water (aqua), C12-15 alkyl benzoate, PEG-8, cetearyl alcohol, acrylates/C12-22 alkyl
methacrylate copolymer, propylene glycol, aloe barbadensis leaf juice, tocopheryl acetate (vitamin
E), sodium ascorbyl phosphate (vitamin C), dicetyl phosphate, ceteth-10 phosphate, potassium
cetyl phosphate, phenoxyethanol, methylparaben, propylparaben, butylparaben, ethylparaben,
isobutylparaben, hydrated silica, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA,
triethanolamine, fragrance (parfum) - Other information
- Label
-
INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH BLOCK UP BROAD SPECTRUM BABY SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-174 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) HYDRATED SILICA (UNII: Y6O7T4G8P9) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-174-05 237 mL in 1 TUBE; Type 0: Not a Combination Product 08/24/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/24/2011 Labeler - Fruit of the Earth, Inc. (079559467)