Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 7.34%
Octocrylene 5%
Octyl Salicylate 5%

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.

When using this product

keep out of eyes.Rinse with water to remove

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

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

Directions

apply generously 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.

Other Information

protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water (Aqua/Eau), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), VP/Eicosene Copolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Dimethicone, Tocopheryl Acetate (Vitamin E Acetate), Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Caprylyl Glycol, Myristyl Laurate, Glyceryl Laurate, Myristyl Myristate, Fragrance (Parfum), Glyceryl Undecylenate, Carbomer, Aminomethyl Propanol.

Package Labeling:53675-206-00

Label

Package Labeling:53675-206-01

Label2

BROAD SPECTRUM SPF15 VERY WATER RESISTANT (80 MINUTES) SUNSCREEN
avobenzone, homosalate, octocrylene, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53675-206
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	73.4 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
JOJOBA OIL (UNII: 724GKU717M)
COCONUT OIL (UNII: Q9L0O73W7L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL LAURATE (UNII: Y98611C087)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53675-206-00	59 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2023
2	NDC:53675-206-01	177 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/02/2023

Labeler - Aruba Aloe Balm NV (855442273)

Broad Spectrum SPF15 Very Water Resistant (80 minutes) Sunscreen