Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 50542a3b-2ef0-452f-b463-79b41e10d1e0
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Zinc Oxide (105 mg)
Inactive Ingredients
Water Cyclomethicone Pentylene Glycol Phenyl Trimethicone Cetostearyl Alcohol Peg-40 Stearate Dimethicone Glycerin Stearyl Alcohol Phenoxyethanol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Ceramide Np Ceramide Ap Ceramide 1 Potassium Cetyl Phosphate Squalane Phytosphingosine Cholesterol Lecithin, Soybean Hydrogenated Palm Glycerides Behentrimonium Methosulfate Polysorbate 60 Hyaluronic Acid Retinol Edetate Disodium Xanthan Gum Iris Germanica Var. Florentina Root Polyoxyl 20 Cetostearyl Ether Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Polysorbate 20 Chlorphenesin Sodium Lauroyl Lactylate Tetrahexyldecyl Ascorbate Alcohol Butylene Glycol Ethylhexylglycerin Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Sodium Polyacrylate (8000 Mw) Sodium Hydroxide Carboxypolymethylene Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-08-28
Description

Octinoxate 7.5% Zinc Oxide 10.5%

Purpose

Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen

Sunscreen

Description

Octinoxate 7.5% Zinc Oxide 10.5%

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

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

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • 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
Questions?

Toll-free number 1-888-768-2915

CeraVe.com

Other Information

protect this product packaging from excessive heat and direct sun

Active Ingredients

Octinoxate 7.5%

Zinc Oxide 10.5%

Inactive Ingredients

water, cyclomethicone, pentylene glycol, phenyl trimethicone, cetearyl alcohol, PEG-40 stearate,

dimethicone, glycerin, stearyl alcohol, phenoxyethanol, hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer, ceramide 3, ceramide 6-II, ceramide 1, potassium cetyl phosphate, squalane, phytosphingosine, cholesterol, lecithin, hydrogenated palm glycerides, behentrimonium methosulfate, polysorbate 60, hyaluronic acid, retinol, disodium EDTA, xanthan gum, iris florentina root extract, ceteareth-20, polysilicone-11, polysorbate 20, chlorphenesin, sodium lauroyl lactylate, tetrahexyldecyl

ascorbate, alcohol, butylene glycol, ethylhexylglycerin, dimethicone crosspolymer-3, sodium polyacrylate, sodium hydroxide, carbomer, citric acid

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

Sunscreen

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

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating
  • 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
Questions?

Toll-free number 1-888-768-2915

CeraVe.com

Other Information (Other information)

protect this product packaging from excessive heat and direct sun

Active Ingredients (Active ingredients)

Octinoxate 7.5%

Zinc Oxide 10.5%

Inactive Ingredients (Inactive ingredients)

water, cyclomethicone, pentylene glycol, phenyl trimethicone, cetearyl alcohol, PEG-40 stearate,

dimethicone, glycerin, stearyl alcohol, phenoxyethanol, hydroxyethyl acrylate, sodium acryloyldimethyl taurate copolymer, ceramide 3, ceramide 6-II, ceramide 1, potassium cetyl phosphate, squalane, phytosphingosine, cholesterol, lecithin, hydrogenated palm glycerides, behentrimonium methosulfate, polysorbate 60, hyaluronic acid, retinol, disodium EDTA, xanthan gum, iris florentina root extract, ceteareth-20, polysilicone-11, polysorbate 20, chlorphenesin, sodium lauroyl lactylate, tetrahexyldecyl

ascorbate, alcohol, butylene glycol, ethylhexylglycerin, dimethicone crosspolymer-3, sodium polyacrylate, sodium hydroxide, carbomer, citric acid

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:37.381510 · Updated: 2026-03-14T23:02:18.218337