Label: COCOOIL SPF 30- octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72645-030-00 - Packager: Cocooil Limited
- Category: HUMAN OTC DRUG LABEL
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 October 31, 2018
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
APPLY liberally 15 minutes before sun exposure
- USE a waterresistant sunscreen if sweating or swimming.
Sun Protection Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 between 10 am and 2 pm
- WEAR long sleeved shirts, pants, hats and sunglasses
- REAPPLY at least every 2 hours
- USE a water resistant sunscreen if sweating or swimming
- Children under 6 months ask a doctor.
- Other information
- Inactive ingredients
- Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
COCOOIL SPF 30
octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72645-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) YELLOW WAX (UNII: 2ZA36H0S2V) TRICONTANYL POVIDONE (UNII: N0SS3Q238D) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72645-030-00 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2018 Labeler - Cocooil Limited (594933650)