Cover Fx Invisible Primer Spf30

Cover Fx Invisible Primer Spf30
SPL v5
SPL
SPL Set ID 2983dd7c-7ca7-e952-e063-6394a90a3098
Route
TOPICAL
Published
Effective Date 2023-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (26 mg)
Inactive Ingredients
Isododecane Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Alkyl (c12-15) Benzoate Butyloctyl Salicylate Caprylyl Trisiloxane Medium-chain Triglycerides Tomato Sesame Seed .alpha.-tocopherol Acetate Squalane Tocopherol Silicon Dioxide Dimethyl Isosorbide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-28

Description

AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 2.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 2.6%

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.

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.
Do Not Use

on damaged or broken skin.

Drug Facts

Questions?

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

Other Information

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

Package Labeling:

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 2.6%

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.

Stop Use and Ask Doctor

if rash occurs.

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out of the Reach of Children.

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


Structured Label Content

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.
Purpose

Sunscreen

Warnings

For external use only.

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.
Do Not Use (Do not use)

on damaged or broken skin.

Drug Facts

Questions?

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

Other Information (Other information)

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

Package Labeling:

Active Ingredients

AVOBENZONE 3%

HOMOSALATE 10%

OCTISALATE 5%

OCTOCRYLENE 2.6%

Inactive Ingredients (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.

Stop Use and Ask Doctor (Stop use and ask doctor)

if rash occurs.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Keep Out of the Reach of Children. (Keep out of the reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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