Skin Balancing Makeup Broad Spectrum Spf 20

Skin Balancing Makeup Broad Spectrum Spf 20
SPL v3
SPL
SPL Set ID 6aee8288-0def-40fc-81f0-604901ccc4a1
Route
TOPICAL
Published
Effective Date 2019-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octinoxate (6 g) Octisalate (4 g) Octocrylene (2.7 g)
Inactive Ingredients
Water Diisopropyl Sebacate Titanium Dioxide Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Stearic Acid Polyethylene Glycol 400 Cyclomethicone Squalane Mica Glyceryl Monostearate Peg-100 Stearate Triethoxycaprylylsilane Di-ppg-3 Myristyl Ether Adipate Polysorbate 60 Ethylhexylglycerin Poly(methyl Methacrylate; 450000 Mw) Propanediol Caprylyl Glycol Hexylene Glycol Methylisothiazolinone Cetyl Alcohol Magnesium Aluminum Silicate Aminomethylpropanol Xanthan Gum .alpha.-tocopherol Acetate Butylene Glycol Magnesium Copper Papaya Glycyrrhiza Glabra

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-01
Description

Active ingredients     Purpose Avobenzone 3%       Sunscreen Octinoxate 6%         Sunscreen Octisalate 4%           Sunscreen Octocrylene 2.7%     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.

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

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 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

Description

Active ingredients     Purpose Avobenzone 3%       Sunscreen Octinoxate 6%         Sunscreen Octisalate 4%           Sunscreen Octocrylene 2.7%     Sunscreen

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/Aqua, Diisopropyl Sebacate, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI77492/CI 77499, Stearic Acid, PEG-8, Cyclomethicone, Squalane, Mica, Glyceryl Stearate, PEG-100 Stearate, Triethoxycaprylylsilane, Di-PPG-3 Myristyl Ether Adipate, Polysorbate 60, Ethylhexylglycerin, Polymethyl Methacrylate, Proanediol, Caprylyl Glycol, Hexylene Glycol, Methylisothiazolinone, Cetyl Alcohol, Magnesium Aluminum Silicate, Aminomethyl Propanol, Xanthan Gum, Tocopheryl Acetate, Butylene Glycol, Magnesium, Copper, Zinc Glycopeptides, Polydodecanamideaminium Triazadiphenylethenesulfonate, Polyvinylalcohol Crosspolymer, Carica papaya Extract, Glycyrhiza Glabra (Licorice)

Section 51945-4

Skin Balancing Makeup

Broad Spectrum SPF 20

30 ml 1 FL OZ

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 ingredients     Purpose

Avobenzone 3%       Sunscreen

Octinoxate 6%         Sunscreen

Octisalate 4%           Sunscreen

Octocrylene 2.7%     Sunscreen

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

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

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 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

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/Aqua, Diisopropyl Sebacate, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI77492/CI 77499, Stearic Acid, PEG-8, Cyclomethicone, Squalane, Mica, Glyceryl Stearate, PEG-100 Stearate, Triethoxycaprylylsilane, Di-PPG-3 Myristyl Ether Adipate, Polysorbate 60, Ethylhexylglycerin, Polymethyl Methacrylate, Proanediol, Caprylyl Glycol, Hexylene Glycol, Methylisothiazolinone, Cetyl Alcohol, Magnesium Aluminum Silicate, Aminomethyl Propanol, Xanthan Gum, Tocopheryl Acetate, Butylene Glycol, Magnesium, Copper, Zinc Glycopeptides, Polydodecanamideaminium Triazadiphenylethenesulfonate, Polyvinylalcohol Crosspolymer, Carica papaya Extract, Glycyrhiza Glabra (Licorice)

Section 51945-4 (51945-4)

Skin Balancing Makeup

Broad Spectrum SPF 20

30 ml 1 FL OZ

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 ingredients     Purpose

Avobenzone 3%       Sunscreen

Octinoxate 6%         Sunscreen

Octisalate 4%           Sunscreen

Octocrylene 2.7%     Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:49.560218 · Updated: 2026-03-14T22:55:34.309870