Label: HEB SHIMMER SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 37808-041-09
- 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 25, 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 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 aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10am-2pm
• wear long-sleeved shirts, pants, hats, and sunglasses.
- Other Information
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Inactive Ingredient(s)
water, tridecyl salicylate, sorbitol, stearic acid, triethanolamine, aluminum starch octenylsuccinate, aloe barbadensis leaf juice, polyethyloxazoline, carbomer, dimethicone, tocopherol, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, sorbitan isostearate, benzyl alcohol, fragrance, polyethylene terephthalate, polyurethane-33, aluminum powder, red 7, yellow 5, titanium dioxide, iron oxides, mica
- Label
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INGREDIENTS AND APPEARANCE
HEB SHIMMER SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-041 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 70 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BENZYL ALCOHOL (UNII: LKG8494WBH) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) MICA (UNII: V8A1AW0880) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLOXAZOLINE (5000 MW) (UNII: HNX7574GTX) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 1.00-2.00) (UNII: KJ6GWA9DJ0) ALUMINUM (UNII: CPD4NFA903) D&C RED NO. 7 (UNII: ECW0LZ41X8) DIMETHICONE (UNII: 92RU3N3Y1O) TROLAMINE (UNII: 9O3K93S3TK) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FERRIC OXIDE RED (UNII: 1K09F3G675) SORBITOL (UNII: 506T60A25R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-041-09 89 mL in 1 TUBE; Type 0: Not a Combination Product 05/08/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/08/2020 Labeler - H.E.B (007924756)
