BALI BODY SHEER GLOW SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene gel

Bali Body Sheer Glow Sunscreen SPF 50 by

Drug Labeling and Warnings

Bali Body Sheer Glow Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake well before use.
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing.
• To decrease the risk, regularly use sunscreen with broad spectrum SPF of 15 or high and other sun protection measures including:
• Limit time in the sun, especially between 10am - 2pm.
• Wear a long sleeve shirt, pants, hats, and sunglasses
• Children under 6 months of age, ask a doctor.

Other information

• Store in a cool, dark place.
• Keep out of direct sunlight and excessive heat.
• Report serious adverse event to AMS Fulfilment 29010 Commerce Centre Drive, Valencia CA 91355

Inactive ingredients

Vitis Vinifera (Grape) Seed Oil, Cocos Nucifera (Coconut) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cocoglycerides, Dibutyl Adipate, Dicaprylyl Carbonate, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, VP/Hexadecene Copolymer, Ethylcellulose, Mica, Fragrance (Parfum), Tocopherol, Tetramethyl Acetyloctahydronaphthalenes, Benzyl Alcohol, Vanillin, Glycine Soja (Soybean) Oil, Benzyl Salicylate, Hydroxycitronellal, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Product Labeling

INGREDIENTS AND APPEARANCE

BALI BODY SHEER GLOW SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCOGLYCERIDES (UNII: ISE9I7DNUG)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
MICA (UNII: V8A1AW0880)
SOYBEAN OIL (UNII: 241ATL177A)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
TOCOPHEROL (UNII: R0ZB2556P8)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CI 77891 (UNII: 15FIX9V2JP)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
CI 77491 (UNII: 1K09F3G675)
GRAPE SEED OIL (UNII: 930MLC8XGG)
COCONUT OIL (UNII: Q9L0O73W7L)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
VP/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
VANILLIN (UNII: CHI530446X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0040-1	95 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2026

Labeler - Bali Body Pty Ltd (757840223)