Complete Lotion Spf 50

Complete Lotion Spf 50
SPL v7
SPL
SPL Set ID d473e7ed-4a9f-76fe-e053-2995a90ab37d
Route
TOPICAL
Published
Effective Date 2022-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octocrylene (9 g) Homosalate (4.5 g) Octisalate
Inactive Ingredients
Isododecane 1,2-hexanediol Glycerin Hydroxyacetophenone Arachidyl Alcohol Arachidyl Glucoside Sodium Ascorbyl Phosphate Butyloctyl Salicylate Ammonium Acryloyldimethyltaurate/beheneth-25 Methacrylate Crosspolymer (52000 Mpa.s) Ethylhexyl Methoxycrylene Polyamide-8 (4500 Mw) Butylene Glycol Docosanol Disodium Edta-copper Styrene/acrylamide Copolymer (mw 500000) Glycereth-26 Alcohol Diisopropyl Adipate Fragrance Fresh Citrus Floral Orc1501495 Water Diethylhexyl Carbonate Dimethicone Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-02
Description

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

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 50565-1

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

Section 50566-9

Stop use and ask a doctor ifrash occurs

Section 50567-7

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not useon damaged or broken skin

Section 51945-4

Coppertone® Sunscreen Lotion

Complete 50

Proven UVA/UVB Protection

+ Moisturizes All Day*

+ Feels Lightweight

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Warnings

For external use only

Directions

■ apply liberally 15 minutes before sun exposure

■ 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 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-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

Questions?

1-866-288-3330

Other Information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Active Ingredients

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

Inactive Ingredients

water, SD alcohol 40-B, butyloctyl salicylate, diethylhexyl carbonate, glycereth-26, styrene/acrylates copolymer, butylene glycol, diisopropyl adipate, dimethicone, polyamide-8, isododecane, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, glycerin, hydroxyacetophenone, ethylhexyl methoxycrylene, arachidyl alcohol, fragrance, xanthan gum, behenyl alcohol, arachidyl glucoside, disodium EDTA, sodium ascorbyl phosphate

Structured Label Content

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 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 50566-9 (50566-9)

Stop use and ask a doctor ifrash occurs

Section 50567-7 (50567-7)

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Section 51945-4 (51945-4)

Coppertone® Sunscreen Lotion

Complete 50

Proven UVA/UVB Protection

+ Moisturizes All Day*

+ Feels Lightweight

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Purpose

Sunscreen

Warnings

For external use only

Directions

■ apply liberally 15 minutes before sun exposure

■ 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 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-sleeve shirts, pants, hats, and sunglasses

■ children under 6 months: Ask a doctor

Questions?

1-866-288-3330

Other Information (Other information)

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

Inactive Ingredients (Inactive ingredients)

water, SD alcohol 40-B, butyloctyl salicylate, diethylhexyl carbonate, glycereth-26, styrene/acrylates copolymer, butylene glycol, diisopropyl adipate, dimethicone, polyamide-8, isododecane, 1,2-hexanediol, ammonium acryloyldimethyltaurate/beheneth-25 methacrylate crosspolymer, glycerin, hydroxyacetophenone, ethylhexyl methoxycrylene, arachidyl alcohol, fragrance, xanthan gum, behenyl alcohol, arachidyl glucoside, disodium EDTA, sodium ascorbyl phosphate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:37.662821 · Updated: 2026-03-14T23:12:10.193103