SUN SHIELD BODY GLOW SPF50- homosalate, octocrylene, octisalate, avobenzone gel

Sun Shield Body Glow SPF50 by

Drug Labeling and Warnings

Sun Shield Body Glow SPF50 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

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

Purpose

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

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

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

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

Uses

Helps prevent sunburn

If used as directed with other sun protectionmeasures (see Directions), decreases the risk ofskin 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 orcontact a Poison Control Center right away

Directions

For Sunscreen use:

Apply generously and evenly 15 minutes before sun exposure.

REAPPLY:

After 40 minutes of swimming or sweating.Immediately after towel drying

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, Fragrance (Parfum), Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Cocos Nucifera (Coconut) Oil, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aleurites Moluccana Seed Oil, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), 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

Sun Shield Body Glow SPF 50

Broad Spectrum

UVA & UVB

40-Minute Sweat &

Water Resistant

& PABA-Free

INGREDIENTS AND APPEARANCE

SUN SHIELD BODY GLOW SPF50 
homosalate, octocrylene, octisalate, avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
AVOCADO OIL (UNII: 6VNO72PFC1)
MACADAMIA OIL (UNII: 515610SU8C)
OCTYLDODECANOL (UNII: 461N1O614Y)
MICA (UNII: V8A1AW0880)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
HIBISCUS SABDARIFFA SEED OIL (UNII: G2X0304IX1)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-001-50	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/28/2024
2	NDC: 84130-001-10	30 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(84130-001)