Label: KROGER BABY SUNSCREEN SPF 50- avobenzone, homosalate ,octisalate, octocrylene spray
- NDC Code(s): 30142-237-50
- 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 17, 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
• Spray liberally and spread evenly by hand 15 minutes before sun exposure
• Hold can 4-6 inches away from the skin to apply
• Do not spray directly into face. Spray into hands then apply to face
• Do not apply in windy conditions
• Use in a well-ventilated area
• 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 Broa 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, butyloctyl salicylate, sorbitol, VP/eicosene copolymer, stearic acid, aloe barbadensis leaf juice, panthenol, tocopherol, sorbitan isostearate, dimethicone, polyglyceryl-3 distearate, disodium EDTA, acrylates/C10-30 alkyl acrylate crosspolymer, styrene/acrylates copolymer, triethanolamine, benzyl alcohol, phenoxyethanol, capryloyl glycine, undecylenoyl glycine
- Label
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INGREDIENTS AND APPEARANCE
KROGER BABY SUNSCREEN SPF 50
avobenzone, homosalate ,octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-237 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 130 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) EDETATE DISODIUM (UNII: 7FLD91C86K) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) TROLAMINE (UNII: 9O3K93S3TK) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) UNDECYLENOYL GLYCINE (UNII: 4D20464K2J) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SORBITOL (UNII: 506T60A25R) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) STEARIC ACID (UNII: 4ELV7Z65AP) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-237-50 178 g in 1 CAN; Type 0: Not a Combination Product 11/25/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 11/25/2019 Labeler - THE KROGER COMPANY (006999528)
