SUNSCREEN SPF 50 PLUS BROAD SPECTRUM UVA UVB PROTECTION- avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream

Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection by

Drug Labeling and Warnings

Sunscreen SPF 50 Plus Broad Spectrum UVA UVB protection 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 5%

Octinoxate 7.5%

Octisalate 5%

Octocrylene 10% 

Oxybenzone 6%

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 of 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 andd other sun protection measures including:
• limit time in the sun, especially from 10 a.m.-2p.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

aloe barbadensis leaf juice (aloe vera gel), caprylyl glycol, chlorophenesin, cocos nucifera oil (coconut oil), dicaprylyl carbonate, dimethicone, fragrance (parfum), pentaerythrityl glutamate, tocopheryl acetate (vitamin E acetate), vp/eicosene copolymer, water (aqua/eau).

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 50 PLUS BROAD SPECTRUM UVA UVB PROTECTION 
avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53675-165
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	50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
COCONUT OIL (UNII: Q9L0O73W7L)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53675-165-00	59 mL in 1 TUBE; Type 0: Not a Combination Product	06/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/10/2017

Labeler - Aruba Aloe Balm NV (855442273)