NDC | 72566-051-06 |
Set ID | 01fd3dc4-b804-424f-94ed-a73c73e0207b |
Category | HUMAN OTC DRUG LABEL |
Packager | OUTLIVING PTY LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- DRUG FACTS
- ACTIVE INGREDIENTS:
- Uses:
- WARNINGS:
-
DIRECTION:
- For sunscreen use
- Apply generously 15 minutes before sun exposure. Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours. Skin Protection Measures. Spending time in the sun increases your risk of skin cancer & early sking aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher & other sun protection measures including:
- Limit time in the sun, especially from 10am-2pm
- Wear long-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months: ask a doctor.
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- QUESTIONS OR COMMENTS?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SUNNYLIFE SPF 50 SUNSCREEN COCONUT SCENTED
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72566-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PEG-15 COCAMINE (UNII: 8L6LB12TSJ) PEG-40 STEARATE (UNII: ECU18C66Q7) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72566-051-06 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/06/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/06/2019 Labeler - OUTLIVING PTY LTD (745474788) Establishment Name Address ID/FEI Business Operations Baxter Laboratories Pty. Ltd. 740537709 manufacture(72566-051)