Protect And Hydrate Radiance Sunscreen Broad Spectrum Spf 50+

Protect And Hydrate Radiance Sunscreen Broad Spectrum Spf 50+
SPL v1
SPL
SPL Set ID 3e4db4f8-cba5-dbfd-e063-6394a90ab0a0
Route
TOPICAL
Published
Effective Date 2025-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (8 g) Homosalate (10 g) Octisalate (5 g) Avobenzone (3 g)
Inactive Ingredients
Water Cetearyl Alcohol .alpha.-tocopherol Acetate Isopropyl Palmitate Benzyl Alcohol Triethanolamine Citric Acid Cyclomethicone Beeswax Carbomer Homopolymer, Unspecified Type Ceteareth-20 Sodium Stearoyl Glutamate Mica Maltodextrin Aloe Barbadensis Leaf Juice Hydroxyacetophenone Phenoxyethanol Titanium Dioxide Ferrous Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-30

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Octisalate5% Octocrylene 8%


Medication Information

Warnings and Precautions

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.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Apply liberally 15 minutes before sun exposure.

apply to all skin exposed to the sun

reapply:

  • 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

  • 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.
  • Children under 6 months: Ask a doctor.
Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Octisalate5% Octocrylene 8%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Water, Beeswax, Cyclomethicone, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Fragrance, Benzyl Alcohol, Hydroxyacetophenone, Carbomer, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Mica, Iron Oxides, Tocopheryl Acetate, Titanium Dioxide, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric

Section 51945-4

Protect & Hydrate Radiance

Shimmer Finish

Sunscreen Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

5.0 fl. oz. (148 mL)

Section 55105-1

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 55106-9

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10%

Octisalate5%

Octocrylene 8%


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure.

apply to all skin exposed to the sun

reapply:

  • 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

  • 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.
  • Children under 6 months: Ask a doctor.
Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Water, Beeswax, Cyclomethicone, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Fragrance, Benzyl Alcohol, Hydroxyacetophenone, Carbomer, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Mica, Iron Oxides, Tocopheryl Acetate, Titanium Dioxide, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric

Section 51945-4 (51945-4)

Protect & Hydrate Radiance

Shimmer Finish

Sunscreen Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

5.0 fl. oz. (148 mL)

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10%

Octisalate5%

Octocrylene 8%


Advanced Ingredient Data


Raw Label Data

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