Label: KROGER SHIMMER SUNSCREEN HYDRATING SPF 40- avobenzone, octisalate, octocrylene cream
- NDC Code(s): 30142-241-09
- Packager: THE KROGER COMPANY
- 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 March 21, 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)
acrylates/C10-30 alkyl acrylate crosspolymer, L-arginine, bismuth oxychloride, butyloctyl salicylate, C12-15 alkyl benzoate, calcium pantothenate, caprylic/capric triglyceride, caprylyl glycol, cetyl phosphate, chlorphenesin, coco-caprylate/caprate, diisopropyl sebacate, ethylhexyl hydroxystearate, ferulic acid, glycerin, glyceryl stearate, helianthus annuus (sunflower) flower extract, 1,2-hexanediol, hydroxyacetophenone, iron oxides, isodecyl neopentanoate, isododecane, lauryl lactate, limonium gerberi extract, mica, niacinamide, phospholipids, polymethylsilsesquioxane, propanediol, sodium hyaluronate, theobroma cacao (cocoa) seed extract, titanium dioxide, tocopherol, triethoxycaprylylsilane, trisodium ethylenediamine disuccinate, water
- Label
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INGREDIENTS AND APPEARANCE
KROGER SHIMMER SUNSCREEN HYDRATING SPF 40
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-241 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) MICA (UNII: V8A1AW0880) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) COCOA (UNII: D9108TZ9KG) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) FERULIC ACID (UNII: AVM951ZWST) LIMONIUM GERBERI FLOWERING TOP (UNII: V4O4C05BJ2) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) STANNIC OXIDE (UNII: KM7N50LOS6) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL PHOSPHATE (UNII: VT07D6X67O) CHLORPHENESIN (UNII: I670DAL4SZ) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) ISODODECANE (UNII: A8289P68Y2) ARGININE (UNII: 94ZLA3W45F) NIACINAMIDE (UNII: 25X51I8RD4) PROPANEDIOL (UNII: 5965N8W85T) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) LAURYL LACTATE (UNII: G5SU0BFK7O) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) PANTOTHENIC ACID (UNII: 19F5HK2737) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-241-09 1 in 1 CARTON 08/25/2022 1 89 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 08/24/2022 Labeler - THE KROGER COMPANY (006999528)