Label: H.E.B MANGO- spf 50 sunscreen lotion
- NDC Code(s): 37808-916-12
- Packager: H.E.B
- Category: HUMAN OTC DRUG LABEL
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 13, 2020
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- 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 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
- Other Information
-
Inactive Ingredient(s)
water, glycerin, silica, aluminum starch octenylsuccinate, behenyl alcohol, phenoxyethanol, glyceryl stearate, arachidyl alcohol, ethylhexylglycerin, arachidyl glucoside, PEG-100 stearate, sodium ascorbyl phosphate, saccharomyces/podophyllum peltatum ferment filtrate, polyester-7, neopentyl glycol diheptanoate, styrene/acrylates copolymer, isododecane, tocopherol (vitamin E), beeswax, potassium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, butylene glycol, fragrance
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
H.E.B MANGO
spf 50 sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-916 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 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DOCOSANOL (UNII: 9G1OE216XY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PHENOXYETHANOL (UNII: HIE492ZZ3T) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) PEG-100 STEARATE (UNII: YD01N1999R) TOCOPHEROL (UNII: R0ZB2556P8) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ISODODECANE (UNII: A8289P68Y2) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) YELLOW WAX (UNII: 2ZA36H0S2V) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-916-12 237 mL in 1 TUBE; Type 0: Not a Combination Product 02/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/07/2019 Labeler - H.E.B (007924756) Registrant - Fruit of the Earth, Inc. (079559467) Establishment Name Address ID/FEI Business Operations Fruit of the Earth, Inc. 008193513 manufacture(37808-916)
