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
Purpose

Sunscreen

Description

Titanium dioxide 6% Zinc oxide 4.7%

Medication Information

Warnings

For external use only

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

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
Other Information

Protect this product from excessive heat and direct sun

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

Description

Titanium dioxide 6% Zinc oxide 4.7%

Questions?

Toll-free number 1-888-768-2915

www.cerave.com

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Titanium dioxide 6%

Zinc oxide 4.7%

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

Warnings

For external use only

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

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
Other Information (Other information)

Protect this product from excessive heat and direct sun

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

Questions?

Toll-free number 1-888-768-2915

www.cerave.com

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Titanium dioxide 6%

Zinc oxide 4.7%

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