Naturium Dew-glow Tinted Moisturizer Spf50-medium

Naturium Dew-glow Tinted Moisturizer Spf50-medium
SPL v3
SPL
SPL Set ID 0d8616a8-2eab-c85c-e063-6294a90a3984
Route
TOPICAL
Published
Effective Date 2023-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Avobenzone (3 g) Octisalate (5 g)
Inactive Ingredients
Niacinamide Sorbitan Monooleate Tocopherol 3-o-ethyl Ascorbic Acid Octadecene Xanthan Gum Polyisobutylene (400000 Mw) Alkyl (c12-15) Benzoate Glyceryl Monostearate Butyloctyl Salicylate Anhydrous Citric Acid Sodium Hydroxide Hydroxyacetophenone Cetearyl Olivate Brown Iron Oxide .alpha.-tocopherol Acetate Hyaluronic Acid Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Water Glycerin Vinylpyrrolidone/eicosene Copolymer .alpha.-bisabolol, (+)- Borosilicate Glass Argan Oil Sodium Stearoyl Glutamate Ammonium Acryloyldimethyltaurate/vp Copolymer Silicon Dioxide 1,2-hexanediol Squalane Sorbitan Olivate Caprylyl/capryl Oligoglucoside Trisodium Ethylenediamine Disuccinate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-27

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0%


Medication Information

Warnings and Precautions

For external use only.

Description

Avobenzone 3.0% Homosalate 10.0% Octisalate 5.0%

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions) , decreases the risk of skin cancer and early signs of aging caused by the sun.

Section 50565-1

if product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

keep out of eyes. Rinse with water to remove.

Section 50570-1

on damaged or broken skin.

Section 51727-6

Aqua/Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Glycerin, Glyceryl Stearate, Ethylhexyl Methoxycrylene, VP/Eicosene Copolymer, Stearyl Dimethicone, Argania Spinosa Kernel Oil, Tocopheryl Acetate, 1,2-Hexandiol, Niacinamide, Sodium Stearoyl Glutamate, Tocopherol, Cetearyl Olivate, Bisabolol, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Squalane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophnone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide

May Contain: Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

Section 51945-4

Section 53413-1

www.naturium.com

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Directions

For sunscreen use:

Apply generously and evenly 15 minutes before sun exposure.

Apply to all skin exposed to the sun.

Use a water-resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m.

Wear long sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.


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 signs of aging caused by the sun.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

if product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

Aqua/Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Glycerin, Glyceryl Stearate, Ethylhexyl Methoxycrylene, VP/Eicosene Copolymer, Stearyl Dimethicone, Argania Spinosa Kernel Oil, Tocopheryl Acetate, 1,2-Hexandiol, Niacinamide, Sodium Stearoyl Glutamate, Tocopherol, Cetearyl Olivate, Bisabolol, 3-O-Ethyl Ascorbic Acid, Sodium Hyaluronate, Squalane, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophnone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Silica, Octadecene, Sorbitan Olivate, Sorbitan Oleate, Caprylyl/Capryl Glucoside, Xanthan Gum, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Trisodium Ethylenediamine Disuccinate, Polyisobutene, Citric Acid, Sodium Hydroxide

May Contain: Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

www.naturium.com

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Directions

For sunscreen use:

Apply generously and evenly 15 minutes before sun exposure.

Apply to all skin exposed to the sun.

Use a water-resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early 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 10:00 a.m. - 2:00 p.m.

Wear long sleeved shirts, pants, hats, and sunglasses.

Children under 6 months of age: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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