GOLDEN AMBER SUN SHIELD BODY GLOW SPF30- avobenzone, homosalate, octisalate, octocrylene gel

Golden Amber Sun Shield Body Glow SPF30 by

Drug Labeling and Warnings

Golden Amber Sun Shield Body Glow SPF30 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 earlyskin 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 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, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor

Inactive ingredients

Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Fragrance (Parfum), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Aleurites Moluccana Seed Oil, Macadamia Ternifolia Seed Oil, Tocopheryl Acetate, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

Other information

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

Questions or comments?

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Golden Amber

Sun Shield Body Glow

Broad Spectrum

UVA-UVB & PABA-FREE

5 FL. OZ. | 150 mL

INGREDIENTS AND APPEARANCE

GOLDEN AMBER SUN SHIELD BODY GLOW SPF30 
avobenzone, homosalate, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
KUKUI NUT OIL (UNII: TP11QR7B8R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
OCTYLDODECANOL (UNII: 461N1O614Y)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+)- (UNII: F4VNO44C09)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
AVOCADO OIL (UNII: 6VNO72PFC1)
HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1)
MACADAMIA OIL (UNII: 515610SU8C)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-003-50	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(84130-003)