Label: HEB- general protection spf 100 lotion lotion
- NDC Code(s): 37808-943-12
- Packager: H-E-B
- 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 March 5, 2020
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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
- 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 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.
- Other information
-
Inactive ingredients
water, propylene glycol, styrene/acrylates copolymer, silica, aluminum starch octenylsuccinate, behenyl alcohol, glyceryl stearate, microcrystalline cellulose, benzyl alcohol, palmitic acid, myristyl alcohol, stearic acid, saccharomyces/podophyllum peltatum ferment filtrate, lauryl alcohol, cetyl alcohol, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, tocopherol (vitamin E), lecithin, cellulose gum, chlorphenesin, butylated PVP, disodium EDTA, butylene glycol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEB
general protection spf 100 lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-943 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) DOCOSANOL (UNII: 9G1OE216XY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) BENZYL ALCOHOL (UNII: LKG8494WBH) PALMITIC ACID (UNII: 2V16EO95H1) MYRISTYL ALCOHOL (UNII: V42034O9PU) STEARIC ACID (UNII: 4ELV7Z65AP) LAURYL ALCOHOL (UNII: 178A96NLP2) CETYL ALCOHOL (UNII: 936JST6JCN) ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) TOCOPHEROL (UNII: R0ZB2556P8) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) N-VINYLPYRROLIDINONE (UNII: 76H9G81541) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-943-12 237 mL in 1 TUBE; Type 0: Not a Combination Product 11/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/12/2019 Labeler - H-E-B (007924756) Registrant - Fruit Of The Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit Of The Earth Research Laboratories, Inc. 008193513 manufacture(37808-943)
