HOLIKA HOLIKA ALOE CICA UV DEFENSE SUNSCREEN- avobenzone, homosalate, octisalate cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Avobenzone 2.70%

Homosalate 9.50%

Octisalate 4.50%

PURPOSE

Purpose

SUNSCREEN

INDICATIONS & USAGE

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

Warnings
■ For external use only
■ Do not use on damaged or broken skin
■ Stop use and ask a doctor if rash occurs
■ When using this product, keep out of eyes. rinse with water to remove
■ Keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away

DOSAGE & ADMINISTRATION

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 of 15 or higher and other sun protection measures including: ■ limited time in the sun, especially from 10 am to 2 pm. ■ wear long-sleeve shirts, pants, hats, and sunglasses ■ Children under 6 months of age: ask a doctor

OTHER SAFETY INFORMATION

Other Information

■ Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

Water, Butyloctyl Salicylate, Propanediol, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Hydrogenated Soy Polyglycerides, Polymethylsilsesquioxane, 1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Centella Asiatica Extract, Centella Asiatica Leaf Extract, Centella Asiatica Root Extract, Pentylene Glycol, Sodium Acrylates Crosspolymer-2, Polyglyceryl-3 Distearate, Potassium Cetyl Phosphate, Cetearyl Olivate, Butylene Glycol, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, C15-23 Alkane, VP/Eicosene Copolymer, Tromethamine, Glyceryl Stearate Citrate, Cetearyl Alcohol, Carbomer, Xanthan Gum, Fragrance(Parfum)

QUESTIONS

Questions?

customerservice@enprani.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOLIKA HOLIKA ALOE CICA UV DEFENSE SUNSCREEN 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69551-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
C15-23 ALKANE (UNII: J3N6X3YK96)
XANTHAN GUM (UNII: TTV12P4NEE)
TROMETHAMINE (UNII: 023C2WHX2V)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CARBOMER (UNII: 0A5MM307FC)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69551-151-02	1 in 1 CARTON	04/01/2026
1	NDC: 69551-151-01	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	04/01/2026

Labeler - Enprani Co., Ltd. (631100112)

Registrant - Enprani Co., Ltd. (631100112)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69551-151)