SUN SHIELD ON-THE-GLOW SHEER STICK SPF40- avobenzone, homosalate, octocrylene, octisalate stick

Sun Shield On-the-Glow Sheer Stick SPF40 by

Drug Labeling and Warnings

Sun Shield On-the-Glow Sheer Stick SPF40 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%, Octocrylene 10%, Octisalate 5%

Purpose

Avobenzone 3%, Homosalate 10%, Octocrylene 10%, Octisalate 5%...................Sunscreen

Uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & 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

Glide onto body, neck and face 15 minutesbefore sun exposure for invisible protection.

Reapply: After 40 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher & 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

C12-15 Alkyl Benzoate, Octyldodecanol, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Isostearyl Linoleate, Dibutyl Lauroyl Glutamide, Polyester-8, Dibutyl Ethylhexanoyl Glutamide, Silica Silylate, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Bisabolol, Fragrance (Parfum), Synthetic Fluorphlogopite, Silica, Hexyl Cinnamal, Benzyl Salicylate, Linalool, Farnesol, Citral, CI 77491 (Iron Oxides)

Other information

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

Questions/Comments

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Kopari

Sun Shield

On-the-Glow

Sheer Stick

Sunscreen SPF 40

1 oz | 30 g

INGREDIENTS AND APPEARANCE

SUN SHIELD ON-THE-GLOW SHEER STICK SPF40 
avobenzone, homosalate, octocrylene, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
LEVOMENOL (UNII: 24WE03BX2T)
LINALOOL, (+)- (UNII: F4VNO44C09)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRAL (UNII: T7EU0O9VPP)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GINGER (UNII: C5529G5JPQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
FARNESOL (UNII: EB41QIU6JL)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-004-10	30 g in 1 CONTAINER; 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(84130-004)