Label: SUNNYLIFE SPF 50 SUNSCREEN COCONUT SCENTED- avobenzone, homosalate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72566-051-06 - Packager: OUTLIVING PTY LTD
- 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 November 8, 2018
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- DRUG FACTS
- ACTIVE INGREDIENTS:
- Uses:
- WARNINGS:
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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:
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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)