SUNNYLIFE SPF 50 SUNSCREEN FRAGRANCE FREE- avobenzone, homosalate, octisalate, octocrylene lotion

SUNNYLIFE SPF 50 SUNSCREEN FRAGRANCE FREE by

Drug Labeling and Warnings

SUNNYLIFE SPF 50 SUNSCREEN FRAGRANCE FREE by is a Otc medication manufactured, distributed, or labeled by OUTLIVING PTY LTD, Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS:

Avobenzone 3%, Homosalate 10%

Ocitsalate 5% Octocrylene 8%

PURPOSE

Sunscreen

Uses:

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & 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 doctor 

   if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help contact Poison Control Center right away.

DIRECTION:

• For sunscreen use
• Apply generously 15 minutes before sun exposure. Reapply: 
• After 80 minutes of swimming or sweating
• Immediately after towel drying 
• At least every 2 hours. Skin Protection Measures. Spending time in the sun increases your risk of skin cancer & early sking aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher & other sun protection measures including:
• Limit time in the sun, especially from 10am-2pm
• Wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor.

OTHER INFORMATION:

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS:

Water, Cera Alba, C12-15 Alkyl Benzoate, SIlica, PEG-15 Cocamine, PEG-40 Stearate, Carbomer, Hydroxyethylcellulose, Caprylhydroxamic Acid, Caprylyl Glycol, Glycerin, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Citric Acid.

QUESTIONS OR COMMENTS?

+1 323.591.0219

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNNYLIFE SPF 50 SUNSCREEN FRAGRANCE FREE 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72566-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-15 COCAMINE (UNII: 8L6LB12TSJ)
PEG-40 STEARATE (UNII: ECU18C66Q7)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72566-050-06	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/06/2019

Labeler - OUTLIVING PTY LTD (745474788)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture(72566-050)