Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 27d82e37-67ac-4cd3-83c0-fb8388d3a0dd
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.80 g) Zinc Oxide (0.63 g)
Inactive Ingredients
Alkyl (c12-15) Benzoate Butyloctyl Salicylate Neopentyl Glycol Diethylhexanoate Paraffin Candelilla Wax Ceresin Dimethicone Yellow Wax High Density Polyethylene Cetyl Alcohol Ceramide Np Ceramide Ap Ceramide 1 Cholesterol Phytosphingosine Hyaluronate Sodium Polyhydroxystearic Acid (2300 Mw) Aluminum Hydroxide Stearic Acid Butylated Hydroxytoluene Triethoxycaprylylsilane Isostearic Acid Sodium Lauroyl Lactylate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-01
Description

Titanium dioxide 6% Zinc oxide 4.7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 6% Zinc oxide 4.7%

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
Section 51945-4

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • 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
Do Not Use

on damaged or broken skin

Questions?

Toll-free number 1-888-768-2915

www.cerave.com

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Titanium dioxide 6%

Zinc oxide 4.7%

Inactive Ingredients

C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Neopentyl Glycol Diethylhexanoate, Paraffin, Euphobia Cerifera (Candelilla) Wax, Ozokerite, Dimethicone, Beeswax, Polyethylene, Cetyl Alcohol, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Polyhydrostearic Acid, Aluminum Hydroxide, Stearic Acid, BHT, Carbomer, Triethoxycaprylylsilane, Isostearic Acid, Sodium Lauroyl Lactylate, Xanthan Gum

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.

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
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • 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
Do Not Use (Do not use)

on damaged or broken skin

Questions?

Toll-free number 1-888-768-2915

www.cerave.com

Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Titanium dioxide 6%

Zinc oxide 4.7%

Inactive Ingredients

C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Neopentyl Glycol Diethylhexanoate, Paraffin, Euphobia Cerifera (Candelilla) Wax, Ozokerite, Dimethicone, Beeswax, Polyethylene, Cetyl Alcohol, Ceramide 3, Ceramide 6-II, Ceramide 1, Cholesterol, Phytosphingosine, Sodium Hyaluronate, Polyhydrostearic Acid, Aluminum Hydroxide, Stearic Acid, BHT, Carbomer, Triethoxycaprylylsilane, Isostearic Acid, Sodium Lauroyl Lactylate, Xanthan Gum

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:37.374539 · Updated: 2026-03-14T23:02:18.218337