NDC | 76138-205-01 |
Set ID | 2cd546eb-33a8-4be5-97e0-bd3ff07cf87f |
Category | HUMAN OTC DRUG LABEL |
Packager | Innovation Specialties |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- 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
5283 SUNSCREEN
octinoxate, octisalate, oxybenzone, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76138-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MYRISTYL PROPIONATE (UNII: P59053E7NJ) PROPYLENE GLYCOL DIOLEATE (UNII: 84T0LSN7U6) CETEARETH-25 (UNII: 8FA93U5T67) PEG-9 DIMETHICONE (400 CST) (UNII: 9OZ27X065D) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Product Characteristics Color Score Shape Size Flavor COCONUT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76138-205-01 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/15/2017 Labeler - Innovation Specialties (030837314)