UVA AND UVB BROAD SPECTRUM SPF30 SUNSCREEN OIL WITH GOLDEN SHIMMER- homosalate, octocrylene, avobenzone oil

UVA and UVB Broad Spectrum SPF30 Sunscreen Oil with golden shimmer by

Drug Labeling and Warnings

UVA and UVB Broad Spectrum SPF30 Sunscreen Oil with golden shimmer by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Homosalate 10% ..................Sunscreen

Octocrylene 8% ....................Sunscreen

Avobenzone 3% ...................Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

For external use only

• Flammable: Do not use near heat, flame, or while smoking
• Do not use on damaged or broken skin
• When using this product, keep out of eyes. Rinse with water to remove.
• If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Apply generously and evenly 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, espicially from 10a.m.-2p.m.
• Wear long sleeve shirts, pants, hats and sunglasses
• Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Paraffinum Liquidum, Isopropyl Palmitate, Isostearyl Neopentanoate, Cocos Nucifera Oil, Silica, Prunus Amygdalus Dulcis Oil, Simmondsia Chinensis Seed Oil, Theobroma Cacao Seed Butter, Parfum, Tocopheryl Acetate, BHT, Mica, CI 77492, Titanium Dioxide, CI 77491, CI 77499, Tin Oxide

STORAGE AND HANDLING

Other information Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

frank body

SPF 30

THE BETTER OIL

UVA + UVB Broad Spectrum SPF30

Sunscreen oil with golden shimmer

3.38fl oz - 100ml

INGREDIENTS AND APPEARANCE

UVA AND UVB BROAD SPECTRUM SPF30 SUNSCREEN OIL WITH GOLDEN SHIMMER 
homosalate, octocrylene, avobenzone oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
STANNIC OXIDE (UNII: KM7N50LOS6)
JOJOBA OIL (UNII: 724GKU717M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
COCONUT OIL (UNII: Q9L0O73W7L)
MICA (UNII: V8A1AW0880)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALMOND OIL (UNII: 66YXD4DKO9)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-008-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	12/01/2022

Labeler - Baxter Laboratories Pty. Ltd. (740537709)