ANTIOXIDANT DAILY FACE PROTECTANT SPF 33- avobenzone, octinoxate, octisalate, oxybenzone cream

Antioxidant Daily Face Protectant SPF 33 by

Drug Labeling and Warnings

Antioxidant Daily Face Protectant SPF 33 by is a Otc medication manufactured, distributed, or labeled by Ibr Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients             Purpose

Avobenzone  1%              Sunscreen

Octinoxate    7.5%           Sunscreen

Octisalate     5%              Sunscreen

Oxybenzone  6%             Sunscreen

PURPOSE

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 eye. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.
• Keep out of reach of childern

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

Directions

Apply liberally 15 minutes before sun exposure.

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 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: 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

KEEP OUT OF REACH OF CHILDREN

Inactive ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Butylene Glycol, Butyloctyl Salicylate, Cyclopentasiloxane, Triethanol-amine, Cyclohexasiloxane, Phoneix Dactylifera (Date) Extract*, Sodium Lactate, Sodium Hyaluronate, Glycerin, Carbomer, Lauryl Methacrylate, /Glycol Dimethacrylate Crosspolymer, Saccharomyces Cerevisiae (Yeast)Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sorbitan Oleate, Polysorbate 20, Tocopherol, Fragrance (Parfum), Benzoic Acid, Butyl Octanol, Ethylhexylglycerin, Linalool, Geraniol, Amyl Cinnamal, Benzyl Slaicylate, Eugenol, BHT, Disodium EDTA, Phenoxyethanol, Caramel, Yellow 5 (CI 19140)

*Phytomelanin TM

SPL UNCLASSIFIED SECTION

Product label

INGREDIENTS AND APPEARANCE

ANTIOXIDANT DAILY FACE PROTECTANT SPF 33 
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75587-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZOIC ACID (UNII: 8SKN0B0MIM)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TROLAMINE (UNII: 9O3K93S3TK)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SODIUM LACTATE (UNII: TU7HW0W0QT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
EUGENOL (UNII: 3T8H1794QW)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARAMEL (UNII: T9D99G2B1R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLOCTANOL (UNII: N442D9VO79)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75587-013-01	1.5 g in 1 PACKAGE; Type 0: Not a Combination Product	09/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/09/2024

Labeler - Ibr Packaging, LLC (081060205)