Bioresist Reinforcing Effect Face Moisturizer Lotion Spf 30

Bioresist Reinforcing Effect Face Moisturizer Lotion Spf 30
SPL v7
SPL
SPL Set ID 99d7525d-b636-7f8e-e053-2a95a90a2080
Route
TOPICAL
Published
Effective Date 2019-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Octocrylene (1.8 g) Avobenzone
Inactive Ingredients
Myristyl Alcohol Acacia Yeast, Unspecified Limonene, (+)- Linalool, (+/-)- .beta.-citronellol, (r)- Stearic Acid Silicon Dioxide Lecithin, Soybean Caprylyl Glycol Butyloctyl Salicylate Docosanol Glyceryl Monostearate Coco-caprylate Water Alkyl (c12-15) Benzoate Ethylhexyl Methoxycrylene Arginine Pyrrolidone Carboxylic Acid Potassium Cetyl Phosphate Palmitic Acid Betasizofiran Edetic Acid Glycerin Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Pullulan Phytate Sodium Phenoxyethanol Lauryl Alcohol Butylene Glycol Squalane Hydroxyacetophenone Xanthan Gum 1,2-hexanediol Cetyl Alcohol Gelatin Hydrolysate (porcine Skin, Mw 3000)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-21
Description

Active Ingredients Purpose Avobenzone 1.80% Sunscreen Octisalate 4.50% Sunscreen Octocrylene 4.50% Sunscreen

Medication Information

Warnings and Precautions

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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

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
  • children under 6 months of age: ask a doctor
Description

Active Ingredients Purpose Avobenzone 1.80% Sunscreen Octisalate 4.50% Sunscreen Octocrylene 4.50% Sunscreen

Section 50565-1

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

Section 51727-6

Inactive ingredients

Water, glycerin, butyloctyl salicylate, c12-15 alkyl benzoate, ethylhexyl methoxycrylene, behenyl alcohol, glyceryl stearate, coco-caprylate, sodium pca, sodium acrylates copolymer, potassium cetyl phosphate, palmitic acid, stearic acid, silica, squalane, lecithin, hydroxyacetophenone, xanthan gum, 1,2- hexandiol, caprylyl glycol, cetyl alcohol, lauryl alcohol, myristyl alcohol, butylene glycol, acacia senegal gum, yeast extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sclerotium gum, tetrasodium edta, pullulan, arginine, fragrance, hydrolyzed algin, sodium phytate, hydrolyzed soybean fiber, phenoxyethanol, nicotiana benthamiana hexapeptide-40 sh-oligopeptide-1, limonene, linalool, citronellol.

Section 55105-1

Uses

Helps prevent Sunburn

Section 55106-9

Active Ingredients Purpose

Avobenzone 1.80% Sunscreen

Octisalate 4.50% Sunscreen

Octocrylene 4.50% Sunscreen

Product Labeling

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

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

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
  • children under 6 months of age: ask a doctor
Warnings and Precautions (34071-1)

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Inactive ingredients

Water, glycerin, butyloctyl salicylate, c12-15 alkyl benzoate, ethylhexyl methoxycrylene, behenyl alcohol, glyceryl stearate, coco-caprylate, sodium pca, sodium acrylates copolymer, potassium cetyl phosphate, palmitic acid, stearic acid, silica, squalane, lecithin, hydroxyacetophenone, xanthan gum, 1,2- hexandiol, caprylyl glycol, cetyl alcohol, lauryl alcohol, myristyl alcohol, butylene glycol, acacia senegal gum, yeast extract, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sclerotium gum, tetrasodium edta, pullulan, arginine, fragrance, hydrolyzed algin, sodium phytate, hydrolyzed soybean fiber, phenoxyethanol, nicotiana benthamiana hexapeptide-40 sh-oligopeptide-1, limonene, linalool, citronellol.

Section 55105-1 (55105-1)

Uses

Helps prevent Sunburn

Section 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 1.80% Sunscreen

Octisalate 4.50% Sunscreen

Octocrylene 4.50% Sunscreen

Product Labeling

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:20.938752 · Updated: 2026-03-14T23:09:05.302478