Label: KROGER BABY SUNSCREEN SPF 50- octisalate, zinc oxide lotion
- NDC Code(s): 30142-220-11
- 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
- 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, C12-15 Alkyl Benzoate, Neopentyl Glycol Diheptanoate, Propylene Glycol, Tridecyl Salicylate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, PEG-12 Dimethicone Crosspolymer, Triethoxycaprylylsilane, Aloe Barbadensis Leaf Juice, Ethylhexyl Palmitate, Caprylyl Glycol, Phexoethanol, Hexylene Glycol, Sodium Chloride.
- Label
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INGREDIENTS AND APPEARANCE
KROGER BABY SUNSCREEN SPF 50
octisalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 145 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CHLORIDE (UNII: 451W47IQ8X) CYCLOMETHICONE 4 (UNII: CZ227117JE) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZOIC ACID (UNII: 8SKN0B0MIM) SORBIC ACID (UNII: X045WJ989B) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) ETHYLHEXYL PALMITATE (UNII: 2865993309) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-220-11 237 mL in 1 BOTTLE; 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)
