Ultra Light Sunscreen Broad Spectrum Spf 50

Ultra Light Sunscreen Broad Spectrum Spf 50
SPL v9
SPL
SPL Set ID 42c43f36-982e-429c-8f2a-2bced1d3b172
Route
TOPICAL
Published
Effective Date 2013-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.39 g) Homosalate (11.3 g) Octisalate (5.65 g) Octocrylene (3.11 g) Oxybenzone (6.78 g)
Inactive Ingredients
Water Cyclomethicone 5 Butyloctyl Salicylate Pentylene Glycol Glycerin Silicon Dioxide Potassium Cetyl Phosphate Dimethicone Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate Polyisobutylene (1000 Mw) Propylene Glycol Glyceryl Monostearate Peg-100 Stearate Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Caprylyl/capryl Oligoglucoside Xanthan Gum Edetate Disodium Butylated Hydroxytoluene Methylisothiazolinone Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-29

Description

Active ingredients        Purpose Avobenzone 3.0%       Sunscreen Homosalate 10.0%      Sunscreen Octisalate 5.0%           Sunscreen Octocrylene 2.75%      Sunscreen Oxybenzone 6.0%       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

• For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure

• use a water resistant sunscreen if swimming or sweating

• reapply 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-sleeved shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Description

Active ingredients        Purpose Avobenzone 3.0%       Sunscreen Homosalate 10.0%      Sunscreen Octisalate 5.0%           Sunscreen Octocrylene 2.75%      Sunscreen Oxybenzone 6.0%       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, Cyclopentasiloxane, Butyloctyl Salicylate, Pentylene Glycol, Glycerin, Silica, Potassium Cetyl Phosphate, Dimethicone, Hydrogenated Palm Glycerides, Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate, Polyisobutene, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Methyl Methacrylate Crosspolymer, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/Dimethicone Copolymer, Trimethylsiloxysilicate, Caprylyl/Capryl Glucoside, Xanthan Gum, Disodium EDTA, BHT, Methylisothiazolinone, Caprylyl Glycol, Fragrance

Section 51945-4

ULTRA LIGHT SUNSCREEN

BROAD SPECTRUM SPF 50

Merle Norman

Established in Los Angeles since 1931

113 g NET WT. 4 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 3.0%       Sunscreen

Homosalate 10.0%      Sunscreen

Octisalate 5.0%           Sunscreen

Octocrylene 2.75%      Sunscreen

Oxybenzone 6.0%       Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

• For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure

• use a water resistant sunscreen if swimming or sweating

• reapply 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-sleeved 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 swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients:

Water, Cyclopentasiloxane, Butyloctyl Salicylate, Pentylene Glycol, Glycerin, Silica, Potassium Cetyl Phosphate, Dimethicone, Hydrogenated Palm Glycerides, Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate, Polyisobutene, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Methyl Methacrylate Crosspolymer, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/Dimethicone Copolymer, Trimethylsiloxysilicate, Caprylyl/Capryl Glucoside, Xanthan Gum, Disodium EDTA, BHT, Methylisothiazolinone, Caprylyl Glycol, Fragrance

Section 51945-4 (51945-4)

ULTRA LIGHT SUNSCREEN

BROAD SPECTRUM SPF 50

Merle Norman

Established in Los Angeles since 1931

113 g NET WT. 4 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 3.0%       Sunscreen

Homosalate 10.0%      Sunscreen

Octisalate 5.0%           Sunscreen

Octocrylene 2.75%      Sunscreen

Oxybenzone 6.0%       Sunscreen


Advanced Ingredient Data


Raw Label Data

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