- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
Directions
•apply liberally 15 minutes before sun exposure
•reapply:
•after 40 minutes of swimming or sweating
•immediately after towel drying
•at least every 2 hours
•Sun Protection Measure. 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 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
- Inactive ingredients
- Other information
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
5281 SUNSCREEN
octocrylene, titanium dioxide, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76138-213 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETETH-25 (UNII: 5KLY4IOG20) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) DMDM HYDANTOIN (UNII: BYR0546TOW) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76138-213-05 15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2018 Labeler - Innovation Specialties (030837314)