Label: MINERAL BASED SPF 50 SUNSCREEN- zinc oxide, titanium dioxide stick
- NDC Code(s): 30142-881-01, 30142-881-91
- 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 April 13, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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.
-
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 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
- Other information
- Inactive ingredients
- Label
-
INGREDIENTS AND APPEARANCE
MINERAL BASED SPF 50 SUNSCREEN
zinc oxide, titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-881 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 70 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 47 mg in 1 g Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETYL ALCOHOL (UNII: 936JST6JCN) CANDELILLA WAX (UNII: WL0328HX19) NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C) CERESIN (UNII: Q1LS2UJO3A) WHITE WAX (UNII: 7G1J5DA97F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ISOSTEARIC ACID (UNII: X33R8U0062) PARAFFIN (UNII: I9O0E3H2ZE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-881-91 1 in 1 BLISTER PACK 12/06/2018 1 NDC:30142-881-01 13.3 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/06/2018 Labeler - THE KROGER COMPANY (006999528)