COCO EVE BODY SUNSCREEN SPF50 PLUS lotion

COCO EVE BODY SUNSCREEN SPF50 plus by

Drug Labeling and Warnings

COCO EVE 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 on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

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 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), Beeswax, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alocohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Citric Acid.

STORAGE AND HANDLING

Other information

Protect the product from excessive heat and direct sun

Questions? Contact (626) 616-5811

PRINCIPAL DISPLAY PANEL

COCO & EVE

BODY SUNSCREEN

SPF 50+

LOTION SOLAIRE
CORPORELLE SPF 50+

UVA + UVB

Broad Spectrum SPF 50+

80 Minutes Water Resistant

Lightweight

Net 200 mL / 6.76 fl. oz. US

COCO & EVE

BODY SUNSCREEN

SPF 50+

LOTION SOLAIRE
CORPORELLE SPF 50+

UVA + UVB

Broad Spectrum SPF 50+

80 Minutes Water Resistant

Lightweight

Net 200 mL / 6.76 fl. oz. US

INGREDIENTS AND APPEARANCE

COCO EVE BODY SUNSCREEN SPF50 PLUS 
coco eve body sunscreen spf50 plus lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82931-003
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)
COCONUT OIL (UNII: Q9L0O73W7L)
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: 82931-003-20	1 in 1 CARTON	01/04/2023
1		200 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(82931-003)