Drug Facts

Active ingredients

Avobenzone 3% Homosalate 15% Octinoxate 7.5%

Octisalate 5%

Purpose

Sunscreen

Uses

Helps prevent sunburn
If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
Limit time in the sun, especially from 10 a.m. – 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun

Inactive ingredients?

Water, Cyclopentasiloxane, Polymethylsilsesquioxane, Polysilicone-15, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Tribehenin, Olive (Olea europaea) Fruit Oil, Damask Rose (Rosa damascena) Flower Oil, Calcium Carbonate, Beeswax, Pollen, Propolis, Silica, Tocopheryl Acetate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Dehydroacetate, Dimethicone, Sodium Hyaluronate, Panthenol, Dimethiconol, Tetrasodium EDTA, Aminomethyl Propanol, Allantoin, Magnesium Aluminum Silicate, Sodium Ascorbate

Package Labeling:

Outer Package Inner Package

CHUDA
avobenzone, homosalate, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71784-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYSILICONE-15 (UNII: F8DRP5BB29)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
OLIVE OIL (UNII: 6UYK2W1W1E)
ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)
CALCIUM CARBONATE (UNII: H0G9379FGK)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLLEN (UNII: 3729L8MA2C)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE SODIUM (UNII: MP1J8420LU)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALLANTOIN (UNII: 344S277G0Z)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBATE (UNII: S033EH8359)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71784-000-00	1 in 1 CARTON	01/01/2015
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	01/01/2015

Labeler - Premier Ocher LLC (046604850)