Drug Facts

Active ingredients

Octocrylene 8%, Octyl methoxycinnamate 7.5%,
Octisalate 5%, Oxybenzone 3%, Avobenzone 2.5%

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 only

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 rash occurs

Keep out of reach of children

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

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

• Protect this product from excessive heat and direct sun

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, TOCOPHEROL

Questions?

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

Package Labeling:

Label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
YELLOW WAX (UNII: 2ZA36H0S2V)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72645-030-00	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/01/2018

Labeler - Cocooil Limited (594933650)