Daily Body Moisturizer Sunscreen Broad Spectrum Spf 50+

Daily Body Moisturizer Sunscreen Broad Spectrum Spf 50+
SPL v1
SPL
SPL Set ID 3e115ef1-f039-4c72-e063-6394a90a7e64
Route
TOPICAL
Published
Effective Date 2025-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (8 g) Avobenzone (3 g) Octisalate (5 g) Homosalate (10 g)
Inactive Ingredients
Beeswax Cyclomethicone Benzyl Alcohol Water Isopropyl Palmitate Carbomer Hydroxyacetophenone .alpha.-tocopherol Acetate Triethanolamine Aloe Barbadensis Leaf Juice Phenoxyethanol Ceteareth-20 Citric Acid Sodium Stearoyl Glutamate Cetostearyl Alcohol Maltodextrin

Identifiers & Packaging

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

Description

Active Ingredient Purpose Avobenzone Sunscreen Homosalate Octisalate Octocrylene


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

Directions

  • Apply liberally 15 minutes before sun exposure
  • Apply to all skin exposed to the sun
  • reapply:
  • after 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 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Description

Active Ingredient Purpose Avobenzone Sunscreen Homosalate Octisalate Octocrylene

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

Inactive ingredients Water, Beeswax, Cyclomethicone, Isopropyl Palmitate, Cetearyl Alcohol, Ceteareth-20, Carbomer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Hydroxyacetophenone, Phenoxyethanol, Triethanolamine, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric Acid

Section 51945-4

Daily Body Moisturizer

SPF 50+

Non-Greasy

Sunscreen Broad Spectrum SPF50+

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 Ingredient Purpose

Avobenzone Sunscreen

Homosalate

Octisalate

Octocrylene

Section 60561-8

Other information

  • protect this product 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 15 minutes before sun exposure
  • Apply to all skin exposed to the sun
  • reapply:
  • after 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 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeve 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)

Inactive ingredients Water, Beeswax, Cyclomethicone, Isopropyl Palmitate, Cetearyl Alcohol, Ceteareth-20, Carbomer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Hydroxyacetophenone, Phenoxyethanol, Triethanolamine, Maltodextrin, Aloe Barbadensis Leaf Juice, Citric Acid

Section 51945-4 (51945-4)

Daily Body Moisturizer

SPF 50+

Non-Greasy

Sunscreen Broad Spectrum SPF50+

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 Ingredient Purpose

Avobenzone Sunscreen

Homosalate

Octisalate

Octocrylene

Section 60561-8 (60561-8)

Other information

  • protect this product from excessive heat and direct sun

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)