SUN SHIELD SOFT GLOW DAILY FACE SPF30- homosalate, octisalate, octocrylene, avobenzone cream

Sun Shield Soft Glow Daily Face SPF30 by

Drug Labeling and Warnings

Sun Shield Soft Glow Daily Face SPF30 by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, Cosmax Usa, Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Avobenzone 3%

Purpose

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

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

Octocrylene 4%......................Sunscreen

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

Uses

Helps prevent sunburn

If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer andearly skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keepout of eyes

Rinse with water to remove

Stop use and ask a doctorif rash occurs

Keep out of reach of children

If product is swallowed, get medicalhelp or contact a Poison Control Center right away

Directions

For Sunscreen use:

Apply generously and 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

Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Methicone, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Titanium Dioxide (Cl 77891), Tocopheryl Acetate, Silica, Tin Oxide, Tocopherol.

Other information

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

Questions or comments?

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Kopari

Sun Shield

Soft Glow

Daily Face

SPF 30

INGREDIENTS AND APPEARANCE

SUN SHIELD SOFT GLOW DAILY FACE SPF30 
homosalate, octisalate, octocrylene, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TOCOPHEROL (UNII: R0ZB2556P8)
MICA (UNII: V8A1AW0880)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNOUS OXIDE (UNII: JB2MV9I3LS)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-006-12	1 in 1 CARTON	06/28/2024
1	NDC: 84130-006-11	44 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 84130-006-22	1 in 1 CARTON	06/28/2024
2	NDC: 84130-006-21	5 mL in 1 TUBE; Type 0: Not a Combination Product

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
Cosmax Usa, Corporation		010990210	manufacture(84130-006)