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

Cocooil SPF50 by

Drug Labeling and Warnings

Cocooil SPF50 by is a Otc medication manufactured, distributed, or labeled by Cocooil Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

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

Octisalate 5%, Oxybenzone 4%, Avobenzone 3%

Purpose

Sunscreen

Uses

• 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.

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

• USE a water resistant sunscreen if sweating or swimming. Sun Protection Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decreases risk, regularly use a sunsreen with a broad spectrum SPF of 15 or higher and other sun protection measures including
• LIMIT time in the sun especially between 10am and 2pm
• 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 sun

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

Package Labeling: 200 ml

INGREDIENTS AND APPEARANCE

COCOOIL SPF50 
homosalate, octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72645-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
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	40 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72645-003-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020
2	NDC: 72645-003-02	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/18/2020

Labeler - Cocooil Limited (594933650)