standard procedure spf 50+ sunscreen face and body lotion

standard procedure spf 50+ sunscreen face and body lotion
SPL v1
SPL
SPL Set ID 34f6150d-9627-94a5-e063-6394a90ad448
Route
topical
Published
Effective Date 2025-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) octisalate (5 g) homosalate (10 g) octocrylene (8 g)
Inactive Ingredients
papaya beeswax ceteareth-20 triethanolamine cyclomethicone 5 cyclomethicone 6 phenoxyethanol aloe vera leaf juice carbomer maltodextrin citric acid cetostearyl alcohol hydroxyacetophenone benzyl alcohol sodium stearoyl glutamate mango water isopropyl palmitate pineapple .alpha.-tocopherol acetate glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-30
Description

Active Ingredients Purpose Avobenzone3%, Homosalate 10%, Octisalate 5%, Octocrylene 8% Sunscreen

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.

Active Ingredient

Active Ingredients Purpose

Avobenzone3%, Homosalate 10%, Octisalate 5%, Octocrylene 8% Sunscreen

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

  • Apply generously and evenly
  • Reapply
  • after 80 minutes of swimming
  • Immediately after towel drying
  • 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor
Description

Active Ingredients Purpose Avobenzone3%, Homosalate 10%, Octisalate 5%, Octocrylene 8% 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, Beeswax, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Citric Acid.

Section 51945-4

Standard Procedure

SPF 50+ sunscreen

For face and body

Broad Spectrum UVA/UVB

80 Minutes Water Resistant

Added Australian Superfruits with Antioxidants and Vitamins A, B + C

Section 53413-1

Questions?

1 213-681-1801 or [email protected]

Section 55105-1

Purpose

Sunscreen

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 60561-8

Other information

  • protect the product in this container from excessive heat and direct sun

Structured Label Content

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.

Active Ingredient (55106-9)

Active Ingredients Purpose

Avobenzone3%, Homosalate 10%, Octisalate 5%, Octocrylene 8% Sunscreen

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

  • Apply generously and evenly
  • Reapply
  • after 80 minutes of swimming
  • Immediately after towel drying
  • 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 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor
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, Beeswax, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Citric Acid.

Section 51945-4 (51945-4)

Standard Procedure

SPF 50+ sunscreen

For face and body

Broad Spectrum UVA/UVB

80 Minutes Water Resistant

Added Australian Superfruits with Antioxidants and Vitamins A, B + C

Section 53413-1 (53413-1)

Questions?

1 213-681-1801 or [email protected]

Section 55105-1 (55105-1)

Purpose

Sunscreen

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 60561-8 (60561-8)

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: 2026-02-15T12:06:20.981638 · Updated: 2026-03-14T23:09:05.302478