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

AGELESS SOLAR DEFENSE (SPF 30) by

Drug Labeling and Warnings

AGELESS SOLAR DEFENSE (SPF 30) by is a Otc medication manufactured, distributed, or labeled by Divine 369 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

Contact us at: contact@audiaskincare.com

Monday - Friday (9am - 5pm PST)

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

www.audiaskincare.com

Package Labeling:

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Divine 369 LLC (081571821)