COCOOIL SPF 30- octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion

COCOOIL SPF 30 by

Drug Labeling and Warnings

COCOOIL SPF 30 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

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:

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)