Ultra Replenishing Sunscreen Spf 40

Ultra Replenishing Sunscreen Spf 40
SPL v5
SPL
SPL Set ID 92ad5d7a-9adb-7d55-e053-2995a90a80e7
Route
TOPICAL
Published
Effective Date 2019-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (80 mg) Octocrylene (50 mg) Zinc Oxide Octisalate
Inactive Ingredients
Steareth-2 Ethylhexylglycerin Chlorphenesin Ferric Oxide Red Silicon Dioxide Titanium Dioxide .alpha.-tocopherol Acetate Kaempferia Galanga Root Aloe Vera Leaf Phytate Sodium Water Glyceryl Monostearate Steareth-21 Mica Alkyl (c12-15) Benzoate Glycerin Polyglyceryl-2 Stearate Vanilla Dimethylmethoxy Chromanol Dimethicone Coconut Oil Citric Acid Monohydrate Stearyl Alcohol Phenoxyethanol Jojoba Oil Fructose English Lavender Oil Withania Somnifera Flower Orange Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-16
Description

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc Oxide 8%

Medication Information

Dosage and Administration

Directions • Apply liberally and evenly 15 minutes before sun exposure. • Reapply: at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating. • 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 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 • Children under 6 months of age: Ask a doctor.













Description

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc Oxide 8%

Uses

Helps prevent sunburn

Section 51727-6

Water C12-15 Alkyl Benzoate Glycerin Mica Polyglyceryl-2 Stearate Glyceryl Stearate Steareth-21 Stearyl Alcohol Dimethicone Phenoxyethanol Simmondsia Chinensis (Jojoba) Seed Oil Steareth-2 Fructose Cocos Nucifera (Coconut) Oil Citric Acid Ethylhexylglycerin Hydroxyethylcellulose Chlorphenesin Hydrolyzed Rice Protein Titanium Dioxide (CI 77891) Tocopheryl Acetate Kaempferia Galanga Root Extract Aloe Barbadensis Leaf Juice Sodium Phytate Lavandula Angustifolia (Lavender) Oil Withania Somnifera Flower Extract Iron Oxide (CI 77492) Iron Oxide (CI 77491) Citrus Aurantium Dulcis (Orange) Peel Oil Silica Dimethylmethoxy Chromanol Vanilla Planifolia Fruit Extract Iron Oxide (CI 77499)































































Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc Oxide 8%





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.

Structured Label Content

Uses

Helps prevent sunburn

Dosage and Administration (34068-7)

Directions • Apply liberally and evenly 15 minutes before sun exposure. • Reapply: at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating. • 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 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 • Children under 6 months of age: Ask a doctor.













Section 51727-6 (51727-6)

Water C12-15 Alkyl Benzoate Glycerin Mica Polyglyceryl-2 Stearate Glyceryl Stearate Steareth-21 Stearyl Alcohol Dimethicone Phenoxyethanol Simmondsia Chinensis (Jojoba) Seed Oil Steareth-2 Fructose Cocos Nucifera (Coconut) Oil Citric Acid Ethylhexylglycerin Hydroxyethylcellulose Chlorphenesin Hydrolyzed Rice Protein Titanium Dioxide (CI 77891) Tocopheryl Acetate Kaempferia Galanga Root Extract Aloe Barbadensis Leaf Juice Sodium Phytate Lavandula Angustifolia (Lavender) Oil Withania Somnifera Flower Extract Iron Oxide (CI 77492) Iron Oxide (CI 77491) Citrus Aurantium Dulcis (Orange) Peel Oil Silica Dimethylmethoxy Chromanol Vanilla Planifolia Fruit Extract Iron Oxide (CI 77499)































































Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc Oxide 8%





Warnings

For external use only.



Do Not Use (Do not use)

on damaged or broken skin.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:21.476970 · Updated: 2026-03-14T23:01:51.692931