Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen

Positive Light Tinted Moisturizer Broad Spectrum Spf 20 Sunscreen
SPL v4
SPL
SPL Set ID cffbb6af-5a04-f58a-e053-2995a90a1ae2
Route
TOPICAL
Published
Effective Date 2021-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (18 mg) Homosalate (90 mg) Zinc Oxide (9 mg)
Inactive Ingredients
Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Lecithin, Soybean Triethoxycaprylylsilane Alkyl (c12-15) Benzoate .alpha.-tocopherol Acetate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Magnesium Sulfate, Unspecified Sodium Dehydroacetate Sunflower Oil Nelumbo Nucifera Flower Ferric Oxide Red Dimethicone Disteardimonium Hectorite Aluminum Hydroxide Aluminum Oxide Propylene Carbonate Sorbitol Isopentyldiol Phenoxyethanol Sodium Chloride Hydrogen Dimethicone (20 Cst) Potassium Sorbate Benzoic Acid Water Dehydroacetic Acid Tocopherol Ethylhexylglycerin Ascorbyl Palmitate Citric Acid Monohydrate Gardenia Jasminoides Fruit Nymphaea Odorata Root Ferric Oxide Yellow Ferrosoferric Oxide Talc Isododecane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-30

Description

Homosalate 9.0% Titanium Dioxide 1.8% Zinc Oxide 0.9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 9.0% Titanium Dioxide 1.8% Zinc Oxide 0.9%

44n

46c

48w

50n

52w

54n

56n

58n

Uses
  • Helps prevent sunburn
Warnings

For external use only.

Directions
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Children under 6 months of age: 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 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
Do Not Use

on damaged or broken skin.

Questions?

Call 1-888-892-7273

Monday-Friday, 7am-4pm PST

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Homosalate 9.0%

Titanium Dioxide 1.8%

Zinc Oxide 0.9%

Company Information

Dist. By Rare Beauty, LLC

El Segundo, CA 90245

Made in Italy

www.rarebeauty.com

Inactive Ingredients

Water/Aqua, Dimethicone, Talc, C12-15 Alkyl Benzoate, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Isopentyldiol, Sorbitol, Tocopheryl Acetate, Phenoxyethanol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Sulfate, Sodium Dehydroacetate, Hydrogen Dimethicone, Potassium Sorbate, Disteardimonium Hectorite, Lecithin, Benzoic Acid, Aluminum Hydroxide, Alumina, Dehydroacetic Acid, Propylene Carbonate, Helianthus Annuus (Sunflower) Seed Oil, Triethoxycaprylylsilane, Tocopherol, Ethylhexylglycerin, Ascorbyl Palmitate, Citric Acid, Gardenia Florida Fruit Extract, Nelumbo Nucifera Flower Extract, Nymphaea Odorata Root Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use If Irritation Occurs

and ask a doctor if a rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help right away.


Structured Label Content

44n (44N)

46c (46C)

48w (48W)

50n (50N)

52w (52W)

54n (54N)

56n (56N)

58n (58N)

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Children under 6 months of age: 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 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
Do Not Use (Do not use)

on damaged or broken skin.

Questions?

Call 1-888-892-7273

Monday-Friday, 7am-4pm PST

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Homosalate 9.0%

Titanium Dioxide 1.8%

Zinc Oxide 0.9%

Company Information

Dist. By Rare Beauty, LLC

El Segundo, CA 90245

Made in Italy

www.rarebeauty.com

Inactive Ingredients

Water/Aqua, Dimethicone, Talc, C12-15 Alkyl Benzoate, Isododecane, Cetyl PEG/PPG-10/1 Dimethicone, Isopentyldiol, Sorbitol, Tocopheryl Acetate, Phenoxyethanol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Sulfate, Sodium Dehydroacetate, Hydrogen Dimethicone, Potassium Sorbate, Disteardimonium Hectorite, Lecithin, Benzoic Acid, Aluminum Hydroxide, Alumina, Dehydroacetic Acid, Propylene Carbonate, Helianthus Annuus (Sunflower) Seed Oil, Triethoxycaprylylsilane, Tocopherol, Ethylhexylglycerin, Ascorbyl Palmitate, Citric Acid, Gardenia Florida Fruit Extract, Nelumbo Nucifera Flower Extract, Nymphaea Odorata Root Extract, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use If Irritation Occurs (Stop use if irritation occurs)

and ask a doctor if a rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help right away.


Advanced Ingredient Data


Raw Label Data

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