Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 4.0%
Avobenzone 3.0%

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.

Stop use and contact your doctor if

rash occurs.

Keep out of reach of children.

If swallowed, get medical help, or contact a poison control center right away.
Do not apply too closely to the eye area. Rinse with water to remove.

Directions

Apply liberally to face and body at least 15 minutes before sun exposure or two minutes before applying makeup.
Reapply:
After 80 minutes of swimming or sweating
Immediately after towel drying.
At least every 2 hours.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and 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:
Limit time in the sun specially, 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 (Aqua), Isopropyl Palmitate, Isoeicosane, Potassium Cetyl Phosphate, Glycerin, Ethylhexyl Methoxycrylene, Silica, Cetyl Dimethicone, Hydroxyethylacrylate/sodium acryloyldimethyl taurate copolymer, Dimethicone, Polyglyceryl-3 Diisostearate, Cetearyl Alcohol, Polysorbate 60, Isohexadecane, Hydroxyethylcellulose, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Butylene Glycol, Punica Granatum (Pomegranate) Extarct, Camellia Oleifera Leaf Extract

Questions or Comments?

Monday - Friday (9am - 5pm PST)

Dist-by Divine 369 LLC. San Francisco CA, 94124

www.audiaskincare.com

Package Labeling:

Label0

AGELESS SOLAR DEFENSE (SPF 30)
octinoxate, octisalate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82084-0011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOEICOSANE (UNII: AR294KAG3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ISOHEXADECANE (UNII: 918X1OUF1E)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POMEGRANATE (UNII: 56687D1Z4D)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82084-0011-0	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/15/2021

Labeler - Divine 369 LLC (081571821)