COVER FX INVISIBLE PRIMER SPF30- avobenzone, homosalate, octisalate, octocrylene lotion

Cover FX Invisible Primer SPF30 by

Drug Labeling and Warnings

Cover FX Invisible Primer SPF30 by is a Otc medication manufactured, distributed, or labeled by Cosmax Usa, Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

AVOBENZONE 3%
HOMOSALATE 10%
OCTISALATE 5%

OCTOCRYLENE 2.6%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection 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 doctor

if rash occurs.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Apply liberally 15 minutes before sun exposure.
• Apply to all skin exposed to the sun.
• Children under 6 months: Ask a doctor.
• Use a water-resistant sunscreen if swimming or sweating.
• 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 take other sun protection measures.
• Limit time in the sun, especially from 10 a.m.-2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses.

Other information

Protect the product in this container from excessive heat and direct sunlight.

Inactive ingredients

ISODODECANE, DIMETHICONE/ BIS-ISOBUTYL PPG-20 CROSSPOLYMER, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, SESAMUM INDICUM (SESAME) SEED EXTRACT, TOCOPHERYL ACETATE, SQUALANE, TOCOPHEROL, SILICA, DIMETHYL ISOSORBIDE.

Questions?

Email: customerservice@cover fx.com M – F, 10 a.m. – 5 p.m. EST

Package Labeling:

INGREDIENTS AND APPEARANCE

COVER FX INVISIBLE PRIMER SPF30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-105
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOMATO (UNII: Z4KHF2C175)
SESAME SEED (UNII: 7Y1255HVXR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-105-00	1 in 1 CARTON	04/28/2023
1		30 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	04/28/2023

Labeler - Cosmax Usa, Corporation (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax Usa, Corporation		010990210	manufacture(68577-105)