Moisturising Sunscreen SPF15

Moisturising Sunscreen SPF15 by

Drug Labeling and Warnings

Moisturising Sunscreen SPF15 by is a Otc medication manufactured, distributed, or labeled by Bali Body Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MOISTURISING SUNSCREEN SPF15- octocrylene, octinoxate, avobenzone, oxybenzone cream 
Bali Body Pty Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Moisturising Sunscreen SPF15

Product Information / Drug Facts

Directions:

Shake well before use. Apply liberally 15 minutes before sun exposure. Children under 6 months old: ask a doctor. Re-apply every 2 hours. Use water-reistant sunscreen if swimming or sweating. Store in a cool dry place.

Warnings / Cautions / Sun safety:

When using this product

keep out of eyes. rinse with water to remove. 

Stop use and a doctor

if rash occurs. 

Do not use

on damaged or broken skin. Wear sun-smart options such as hat and sunglasses.

Keep out of reach of children.

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active ingredients:

Octocrylene 6%
Octinoxate 4.9%
Avobenzone 3%
Oxybenzone 3%

Purpose:

Sunsreen

Inactive ingredients:

Water (Aqua), Dicaprylyl Carbonate, Ethylhexyl Stearate, Glyceryl Stearate, Potassium Cetyl Phosphate, Vitis Vinifera (Grape) Seed Oil, Glycerin, Cetearyl Olivate, Cetearyl Alcohol, Aloe Barbadenis Leaf Juice Powder, Prunus Amygdalus Dulci (Sweet Almond) Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinesis (Jojoba) Seed Oil, Rosa Canina Fruit Oil, Citrus Paradisi (Grapefruit) Peel Oil, Glycine Soja (Soybean) Oil, Sorbitan Olivate, Tocopherol, BHT, Sodium Citrate, Citric Acid, Fragrance (Parfum), Hexyl Cinnamal*, Phenoxyethanol, Ethyylhexylglycerin, Benzyl Alcohol.

Package Labeling:

MOISTURISING SUNSCREEN SPF15 
octocrylene, octinoxate, avobenzone, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70630-0015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	49 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALMOND OIL (UNII: 66YXD4DKO9)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
GRAPEFRUIT OIL (UNII: YR377U58W9)
SOYBEAN OIL (UNII: 241ATL177A)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70630-0015-1	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2021	08/31/2021

Labeler - Bali Body Pty Ltd (757840223)

Revised: 12/2021

Document Id: d28ef437-516b-48d6-e053-2995a90a52fa

34390-5

Set id: a6e8079e-b108-4022-ac86-b352e0977855

Version: 2

Effective Time: 20211207