OLIVIA AND ALLISON AQUA SKIN SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream 
Makeup S.he, Inc.

----------

Olivia and Allison AQUA SKIN SUNSCREEN

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

MAKEUPSHE_Aaua skin sunscreen

OLIVIA AND ALLISON AQUA SKIN SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84122-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.35 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.65 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84122-050-021 in 1 BOX02/26/2024
1NDC:84122-050-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/26/2024
Labeler - Makeup S.he, Inc. (005613587)
Establishment
NameAddressID/FEIBusiness Operations
Rebom Co., Ltd.695951708manufacture(84122-050)

Revised: 2/2024
Document Id: 11762d42-215b-7812-e063-6294a90a077c
Set id: 11762d42-215a-7812-e063-6294a90a077c
Version: 1
Effective Time: 20240215
 
Makeup S.he, Inc.