COCOOIL SPF50- homosalate, octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion 
Cocooil Limited

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.

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Cocooil SPF50

Drug Facts

Active ingredients

Homosalate 10%, Octocrylene 8%, Octyl methoxycinnamate 7.5%

Octisalate 5%, Oxybenzone 4%, Avobenzone 3%

Purpose

Sunscreen

Uses

Warnings

For external use ony

Do not use

  • on damaged or broken skin   

When using this product 

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

  • if a rash occurs

Keep out of reach of children

  • If this product is swallowed get medical help or contact a Poison Control Center right away.

Directions

APPLY liberally 15 minutes before sun exposure

Other Information

Inactive ingrediets

CAPRYLIC/CAPROC TRIGLYCERIDE, HELIANTHUS ANNUUS SEED OIL, Cold pressed organic COCOS NUCIFERA OIL, C12-15 ALKYL BENZOATE, BEESWAX, BUTYROSPERMUM PARKII BUTTER, TRIACONTANYL PVP, PARFUM, TOCOPHEROL

Questions?

Visit www.cocooil.com.au or call +64 9 361 4191

Package Labeling: 100 ml

Bottle2

Package Labeling: 200 ml

Bottle3

COCOOIL SPF50 
homosalate, octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72645-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72645-003-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
2NDC:72645-003-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/18/2020
Labeler - Cocooil Limited (594933650)

Revised: 5/2020
Document Id: a4d771ca-7450-828c-e053-2995a90a3061
Set id: a4d7855b-c9ac-c8de-e053-2995a90ae4b0
Version: 1
Effective Time: 20200504
 
Cocooil Limited