Label: HEB SOLUTIONS SUNSCREEN ULTRA 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 37808-941-12
- 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 October 3, 2022
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- Download DRUG LABEL INFO: PDF XML
- 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 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 ingredients
water, propylene glycol, 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 SOLUTIONS SUNSCREEN ULTRA 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-941 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 70 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) DOCOSANOL (UNII: 9G1OE216XY) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MYRISTYL ALCOHOL (UNII: V42034O9PU) LAURYL ALCOHOL (UNII: 178A96NLP2) PALMITIC ACID (UNII: 2V16EO95H1) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CHLORPHENESIN (UNII: I670DAL4SZ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BENZYL ALCOHOL (UNII: LKG8494WBH) TOCOPHEROL (UNII: R0ZB2556P8) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CETYL ALCOHOL (UNII: 936JST6JCN) CHAMOMILE (UNII: FGL3685T2X) N-VINYLPYRROLIDINONE (UNII: 76H9G81541) YEAST (UNII: 3NY3SM6B8U) PODOPHYLLUM (UNII: 2S713A4VP3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-941-12 237 mL in 1 TUBE; Type 0: Not a Combination Product 02/06/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/06/2013 Labeler - H-E-B (007924756)
