Label: COCOOIL SPF 30- octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion
- NDC Code(s): 72645-030-00
- Packager: Cocooil Limited
- 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.
Updated October 31, 2018
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredients
Octocrylene 8%, Octyl methoxycinnamate 7.5%,Close
Octisalate 5%, Oxybenzone 3%, Avobenzone 2.5%
• helps prevent sunburn • if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.Close
For external use only
Keep out of reach of children
- If this product is swallowed get medical help or contact a Poison Control Centre right away.
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
• Protect this product from excessive heat and direct sunClose
- Inactive ingredients
CAPRYLIC/CAPRIC TRIGLYCERIDE, HELIANTHUS ANNUUS SEED OIL, Cold pressed certified organic COCOS NUCIFERA OIL, C12-15 ALKYL BENZOATE, BEESWAX, BUTYROSPERMUM PARKII BUTTER, TRIACONTANYL PVP, PARFUM, TOCOPHEROLClose
Visit www.cocooil.com.au or call +64 9 361 4191Close
- Package Labeling:
- INGREDIENTS AND APPEARANCE
COCOOIL SPF 30
octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion
Product 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)