Label: KROGER BABY SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 30142-821-12
- Packager: THE KROGER COMPANY
- 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 May 11, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
-
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
- 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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KROGER BABY SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-821 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 130 mg in 1 mL 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 70 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-821-12 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/30/2016 Labeler - THE KROGER COMPANY (006999528) Registrant - FRUIT OF THE EARTH, INC. (079559467) Establishment Name Address ID/FEI Business Operations FRUIT OF THE EARTH, INC. 080086802 manufacture(30142-821)
