ROSE GOLD SUN SHIELD BODY GLOW SPF45- avobenzone, homosalate, octocrylene, octisalate gel

Rose Gold Sun Shield Body Glow SPF45 by

Drug Labeling and Warnings

Rose Gold Sun Shield Body Glow SPF45 by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, Biogenesis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

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

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

Octisalate 5% .............................Sunscreen

Octocrylene 10% ........................Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sunprotection 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

Apply generously & evenly 15 minutes before sun exposure.

REAPPLY: At least every 40 minutes 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, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask doctor

Inactive ingredients

Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Aleurites Moluccana Seed Oil, Macadamia Ternifolia Seed Oil, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Hibiscus Sabdariffa Seed Oil, Persea Gratissima (Avocado) Oil, Fragrance (Parfum), Triethoxycaprylylsilane, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Alpha Isomethyl Ionone, Benzyl Benzoate, Coumarin, Hexyl Cinnamal, Limonene, Synthetic Fluorphlogopite, Mica, Tin Oxide, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Other information

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

Questions or comments?

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Rose Gold

Sun Shield Body Glow

Broad Spectrum

Sunscreen SPF 45

UVA-UVB

& PABA-FREE

5 Fl. Oz. | 150 mL

INGREDIENTS AND APPEARANCE

ROSE GOLD SUN SHIELD BODY GLOW SPF45 
avobenzone, homosalate, octocrylene, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
OCTYLDODECANOL (UNII: 461N1O614Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
KUKUI NUT OIL (UNII: TP11QR7B8R)
COCONUT OIL (UNII: Q9L0O73W7L)
HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BENZYL BENZOATE (UNII: N863NB338G)
MICA (UNII: V8A1AW0880)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
COUMARIN (UNII: A4VZ22K1WT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
AVOCADO OIL (UNII: 6VNO72PFC1)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
MACADAMIA OIL (UNII: 515610SU8C)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-002-50	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/28/2024

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture(84130-002)