Protect & Prime Broad Spectrum Spf30

Protect & Prime Broad Spectrum Spf30
SPL v5
SPL
SPL Set ID cdd6ffe3-2ae6-44d8-a9b8-45bb134e928c
Route
TOPICAL
Published
Effective Date 2016-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (75 mg) Octocrylene (100 mg) Oxybenzone (60 mg)
Inactive Ingredients
Water Medium-chain Triglycerides Simmondsia Chinensis Seed Wax Helianthus Annuus Seed Wax Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Schinziophyton Rautanenii Seed Oil Shea Butter Stearic Acid Glycerin 1,4-butanediol Monostearate Phenoxyethanol Benzyl Alcohol Sodium Stearoyl Glutamate .alpha.-tocopherol Acetate Geraniol .beta.-citronellol, (r)- Xanthan Gum Linalool, (+/-)- Aluminum Oxide Aluminum Stearate Edetate Disodium Ethylhexylglycerin Dehydroacetic Acid Silicon Dioxide Sodium Stearate Disodium Rutinyl Disulfate Barley Melissa Officinalis Leaf Sodium Benzoate Citral Citric Acid Monohydrate Farnesol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-03
Description

Avobenzone 3% Octinoxate 7.5% Octocrylene 10% Oxybenzone 6%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Octinoxate 7.5% Octocrylene 10% Oxybenzone 6%

Use
  • Helps prevent sunburn
Warnings

For external use only

Directions
  • Apply generously 15 minutes before sun exposure
  • Use a Water Resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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: Sun Protection Measures.
  • 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

Drug Facts

Package Labling:

Other Information
  • Protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 10%

Oxybenzone 6%

Inactive Ingredients

Water (Aqua), caprylic/capric triglyceride, Green Wattle (Acacia Decurrens)/Jojoba (Simmondsia Chinensis)/Sunflower (Helianthis Annus) Seed Wax/Polyglyceryl-3 Esters, HDI/Trimethylol Hexyllactone Crosspolymer, Tapioca Starch, Manketti (Schinziophyton Rautaneii) Kernel Oil, Shea Butter (Vitellaria Paradoxa), Stearic Acid, Glycerin, Butylene Glycol Stearate SE, Phenoxyethanol, Benzyl Alcohol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Fragrance (Parfum), Polyhydroxystearic Acid, Geraniol, Limonene, Citronellol, Xanthan Gum, Linalool, Alumina, Aluminum Stearate, Disodium EDTA, Ethylhexylglycerin, Dehydroacetic Acid, Silica, Sodium Stearate, Polymethylsilsesquioxane, Disodium Rutinyl Disulfate, Barley (Hordeum Districhon) Extract, Lemon Balm (Melissa Officinalis) Leaf Extract, Sodium Benzoate, Citral, Citric Acid, Farnesol, Titanium Dioxide (CI 77891)

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

Use
  • Helps prevent sunburn
Purpose

Sunscreen

Warnings

For external use only

Directions
  • Apply generously 15 minutes before sun exposure
  • Use a Water Resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • 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: Sun Protection Measures.
  • 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

Drug Facts

Package Labling:

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 10%

Oxybenzone 6%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), caprylic/capric triglyceride, Green Wattle (Acacia Decurrens)/Jojoba (Simmondsia Chinensis)/Sunflower (Helianthis Annus) Seed Wax/Polyglyceryl-3 Esters, HDI/Trimethylol Hexyllactone Crosspolymer, Tapioca Starch, Manketti (Schinziophyton Rautaneii) Kernel Oil, Shea Butter (Vitellaria Paradoxa), Stearic Acid, Glycerin, Butylene Glycol Stearate SE, Phenoxyethanol, Benzyl Alcohol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Fragrance (Parfum), Polyhydroxystearic Acid, Geraniol, Limonene, Citronellol, Xanthan Gum, Linalool, Alumina, Aluminum Stearate, Disodium EDTA, Ethylhexylglycerin, Dehydroacetic Acid, Silica, Sodium Stearate, Polymethylsilsesquioxane, Disodium Rutinyl Disulfate, Barley (Hordeum Districhon) Extract, Lemon Balm (Melissa Officinalis) Leaf Extract, Sodium Benzoate, Citral, Citric Acid, Farnesol, Titanium Dioxide (CI 77891)

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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:19.047806 · Updated: 2026-03-14T23:01:48.065872