SAND SKY AUSTRALIAN SUNSHIELD BODY SUNSCREEN SPF50 PLUS lotion

Sand Sky Australian Sunshield Body Sunscreen SPF50 plus by

Drug Labeling and Warnings

Sand Sky Australian Sunshield Body Sunscreen SPF50 plus by is a Otc medication manufactured, distributed, or labeled by Supernova USA Inc., Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active Ingredients Homosalate 10%Octocrylene 8%Octisalate 5%Avobenzone 3%: Purpose ; Sunscreen; Sunscreen; Sunscreen; Sunscreen

INDICATIONS & USAGE

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

Warnings

For external use only.

Store below 30°C / 86°F and avoid direct sunlight.

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION

Directions

• Apply an even layer of this lotion on skin 20 minutes before sun exposure.
• Reapply frequently especially after swimming, swaeting, or towelling.
• 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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2. p.m.
  • Wear a long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients Water (Aqua), Bees Wax, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Terminalia Ferdinandiana Fruit Extract, Glycerin, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Carbomer, Hydroxyacetophenone, Benzyl Alcohol, Phenoxyethanol, Triethanolamine, Citric Acid.

STORAGE AND HANDLING

Other information

Protect the product from excessive heat and direct sun

Questions? Contact (626) 616-5811

PRINCIPAL DISPLAY PANEL

SAND
& SKY

Australian
Sunshield

Body Sunscreen SPF50+
Lotion Solaire Corporelle SPF50+

UVA + UVB
Board Spectrum SPF50+
80 Minutes Water Resistant
Lightweight

Net 190 mL / 6.42 fl. oz. US

PRINCIPAL DISPLAY PANEL

SAND
& SKY

Australian
Sunshield

Body Sunscreen SPF50+
Lotion Solaire Corporelle SPF50+

+ Vitamin E
+ Aloe Vera

UVA + UVB
Board Spectrum SPF50+
80 Minutes Water Resistant
Lightweight

Net 190 mL / 6.42 fl. oz. US

INGREDIENTS AND APPEARANCE

SAND SKY AUSTRALIAN SUNSHIELD BODY SUNSCREEN SPF50 PLUS 
sand sky australian sunshield body sunscreen spf50 plus lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82931-004
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	WHITE (white to off-white to light orange pink )	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82931-004-19	1 in 1 CARTON	01/04/2023
1		190 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/04/2023

Labeler - Supernova USA Inc. (116909952)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	MANUFACTURE(82931-004)