OLIVIA AND ALLISON AQUA SKIN SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

Olivia and Allison AQUA SKIN SUNSCREEN by

Drug Labeling and Warnings

Olivia and Allison AQUA SKIN SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Makeup S.he, Inc., Rebom Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%

Homosalate 7.3%

Octisalate 5.0%

Octocrylene 8.7%

Purpose

sunscreen

Uses

■ helps prevent sunburn ■ higher SPF gives more sunburn protection

■ 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 the product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

■ apply liberally 15 minutes before sun exposure. 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 ■ reapply at least every 2 hours. ■ use a water-resistant sunscreen if swimming or sweating.

Other information

■ protect the product in this container from excessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Water, Butyloctyl Salicylate, Cetearyl Alcohol, Poly C10-30 Alkyl Acrylate, Dicaprylyl Carbonate, Cetearyl Glucoside, Niacinamide, Dipropylene Glycol, Sorbitan Olivate, Polymethylsilsesquioxane, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Arginine, Carbomer, Butylene Glycol, Hydroxypropyl Methylcellulose Stearoxy Ether, Tocopheryl Acetate, Disodium EDTA, Xanthan Gum, Ethylhexylglycerin, Adenosine, Bambusa Vulgaris Leaf Extract, Oldenlandia Diffusa Extract, Lonicera Caprifolium (Honeysuckle) Extract, Yeast Extract, Limonia Acidissima Extract, 1,2-Hexanediol, Glycerin, Tocopherol, Ethyl Hexanediol, Centella Asiatica Extract, Madecassic Acid, Asiaticoside, Asiatic Acid, Fragrance, Geraniol, Butylphenyl Methylpropional, Linalool, Benzyl Benzoate, Hexyl Cinnamal, Limonene

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OLIVIA AND ALLISON AQUA SKIN SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84122-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.35 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3.65 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ASIATICOSIDE (UNII: PKO39VY215)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
BENZYL BENZOATE (UNII: N863NB338G)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ETHOHEXADIOL (UNII: M9JGK7U88V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
XANTHAN GUM (UNII: TTV12P4NEE)
GERANIOL (UNII: L837108USY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BAMBUSA VULGARIS LEAF (UNII: EMY54R518C)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ASIATIC ACID (UNII: 9PA5A687X5)
WATER (UNII: 059QF0KO0R)
MADECASSIC ACID (UNII: M7O1N24J82)
SCLEROMITRION DIFFUSUM (UNII: 291PPU5K9I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
YEAST (UNII: 3NY3SM6B8U)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SORBITAN OLIVATE (UNII: MDL271E3GR)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PANTHENOL (UNII: WV9CM0O67Z)
ARGININE (UNII: 94ZLA3W45F)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84122-050-02	1 in 1 BOX	02/26/2024
1	NDC: 84122-050-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/26/2024

Labeler - Makeup S.he, Inc. (005613587)

Establishment
Name	Address	ID/FEI	Business Operations
Rebom Co., Ltd.		695951708	manufacture(84122-050)