BROAD SPECTRUM SPF30 VERY WATER RESISTANT (80 MINUTES) SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate cream

Broad Spectrum SPF30 Very Water Resistant (80 Minutes) Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF30 Very Water Resistant (80 Minutes) Sunscreen by is a Otc medication manufactured, distributed, or labeled by Aruba Aloe Balm NV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:30ml

Package Labeling:59ml

Package Labeling:177ml

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF30 VERY WATER RESISTANT (80 MINUTES) SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-207-00	30 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2023
2	NDC: 53675-207-01	59 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2023
3	NDC: 53675-207-02	177 mL in 1 TUBE; Type 0: Not a Combination Product	06/02/2023

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

Labeler - Aruba Aloe Balm NV (855442273)