Label: HEB SPF 50 PINK PEONY SUNSCREEN- avobenzone, homosalate, octisalate,octocrylene lotion
- NDC Code(s): 37808-048-12
- Packager: H.E.B
- 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 February 26, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- 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 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
- Other Information
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Inactive Ingredient(s)
water, polyester-7, neopentyl glycol diheptanoate, glycerin, cetearyl olivate, styrene/acrylates copolymer, sorbitan olivate, aluminum starch octenylsuccinate, olive oil polyglyceryl-6 esters, saccharomyces/podophyllum peltatum ferment filtrate, butylene glycol, silica, phenoxyethanol, isododecane, sodium stearoyl lactylate, cetearyl alcohol, cetyl palmitate, sorbitan palmitate, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, tocopherol (vitamin E), potassium hydroxide, sodium ascorbyl phosphate, fragrance.
- Label
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INGREDIENTS AND APPEARANCE
HEB SPF 50 PINK PEONY SUNSCREEN
avobenzone, homosalate, octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-048 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) POLYESTER-7 (UNII: 0841698D2F) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ISODODECANE (UNII: A8289P68Y2) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) CETYL PALMITATE (UNII: 5ZA2S6B08X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PODOPHYLLUM (UNII: 2S713A4VP3) SORBITAN OLIVATE (UNII: MDL271E3GR) OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I) CETEARYL OLIVATE (UNII: 58B69Q84JO) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-048-12 237 mL in 1 TUBE; Type 0: Not a Combination Product 03/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 03/22/2021 Labeler - H.E.B (007924756)
