Cetaphil Hydrating Face Sunscreen Spf 35 Lotion
FDA Label NDC 0299-4142

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galderma Laboratories, L.p. for the product Cetaphil Hydrating Face Sunscreen Spf 35 (NDC 0299-4142). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, otc - purpose section, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Avobenzone 2.8% .................Sunscreen
Homosalate 9.5% .....................Sunscreen
Octisalate 4.8% ..................Sunscreen
Octocrylene 7% .................Sunscreen

Otc - Purpose Section

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 A Doctor If

rash occurs.

Keep Out Of Reach Of Children.

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

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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

Other Information

  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics

Inactive Ingredients

Water, Glycerin, Dipropylene Glycol, Panthenol (Vitamin B5), Ethylhexyl Methoxycrylene, lsopropyl Palmitate, Silica, Niacinamide, Cetearyl Olivate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E Acetate), Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Leontopodium Alpinum Flower/Leaf Extract, 1,2-Hexanediol, Oryza Saliva (Rice) Lees Extract, Propanediol, Sodium Hydroxide, Adenosine, Citric Acid, Myristic Acid, Tocopherol (Vitamin E), Buddleja Davidii (Summer Lilac) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract

Questions Or Comments?

1-866-735-4137

Principal Display Panel - 3 Fl Oz Carton

Hydrating Face Sunscreen (085164 P57554 0 Hydrating Face Spf 35 3oz Carton)

Hydrating Face Sunscreen (085164 P57554 0 Hydrating Face Spf 35 3oz Carton)

NEW
DERMATOLOGIST RECOMMENDED
FOR SENSITIVE SKIN

Cetaphil®

SUN
35

Hydrating Face
Sunscreen
Broad Spectrum SPF 35

Formulated for sensitive skin

Oil-free, lightweight
sunscreen hydrates and 
protects against
sun damage

Antioxidant Vitamins B3 and E
plus Vitamin B5

Skin Cancer Foundation logo

3 FL OZ (88 mL)


Distributed by:
Galderma Laboratories, L.P.
Dallas, Texas 75201 USA
All trademarks are the property of their respective owners.
cetaphil.com
P57554-0












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