SPL v1
SPL
SPL Set ID 0813c3dd-9a24-174b-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2014-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.6 g) Titanium Dioxide (4.1 g) Zinc Oxide (.4 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-11-20

Description

OCTINOXATE 4.0% TITANIUM DIOXIDE 10.2%, ZINC OXIDE 1.0%

Purpose

Sunscreen Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Description

OCTINOXATE 4.0% TITANIUM DIOXIDE 10.2%, ZINC OXIDE 1.0%

Section 51945-4

COLOR CONTROL

CC

CREAM

PURE CC

SUNSCREEN CREAM SPF30

02 NATURAL BEIGE

Section 53413-1

Questions or comments? Call 1 (866) 638-8417

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.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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

Directions

Apply generously and evenly 15 minutes before

sun exposure.

Children under 6 months of age: Ask a doctor

Skin Cancer/Skin Aging Alert: Spending time in

the sun increases your risk of skin cancer and early

skin aging. This product has been shown only to

help prevent sunburn, not skin cancer or early skin

aging.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

Dispense an adequate amount at the last stage of

your skincare and apply evenly on the face.

To keep your face looking fresh, use with Face it Aura CC

Cream.

Distributed By:

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

Other Information

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

May stain or damage some fabrics or surfaces

Active Ingredients

OCTINOXATE 4.0%

TITANIUM DIOXIDE 10.2%,

ZINC OXIDE 1.0%

Inactive Ingredients

WATER•CYCLOPENTASILOXANE•CYCLOHEXASILOXANE•PHENYL

TRIMETHICONE•GLYCERIN•BUTYLENE GLYCOL DICAPRYLATE/

DICAPRATE•DIMETHICONE•BUTYLENE GLYCOL•PEG-8•

NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•PENTYLENE

GLYCOL•SODIUM CHLORIDE•DICAPRYLYL CARBONATE•

SORBITAN ISOSTEARATE•DISTEARDIMONIUM HECTORITE•

C30-45 ALKYLDIMETHYLSILYL POLYPROPYLSILSESQUIOXANE•

PHENOXYETHANOL•DIMETHICONE CROSSPOLYMER•

TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE•STEARIC

ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DISODIUM EDTA•

VITIS VINIFERA (GRAPE) FRUIT EXTRACT•OENOTHERA BIENNIS

(EVENING PRIMROSE) OIL•ONSEN-SUI•SODIUM PCA•UREA•

POLYPERFLUOROMETHYLISOPROPYL ETHER•LONICERA

JAPONICA (HONEYSUCKLE) FLOWER EXTRACT•IMPERATA

CYLINDRICA ROOT EXTRACT•TREHALOSE•POLYQUATERNIUM-51•

CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•

ACHYRANTHES FAURIEI ROOT EXTRACT•SODIUM

HYALURONATE•TRIACETIN•CAPRYLYL GLYCOL•1,2-HEXANEDIOL•

CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•OXYGEN•

BUTYLPARABEN•ETHYLPARABEN•PROPYLPARABEN•

ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•

MICA (CI 77019)•IRON OXIDES (CI 77491,

CI 77492, CI 77499)


Structured Label Content

Section 51945-4 (51945-4)

COLOR CONTROL

CC

CREAM

PURE CC

SUNSCREEN CREAM SPF30

02 NATURAL BEIGE

Section 53413-1 (53413-1)

Questions or comments? Call 1 (866) 638-8417

Purpose

Sunscreen

Sunscreen

Sunscreen

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.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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

Directions

Apply generously and evenly 15 minutes before

sun exposure.

Children under 6 months of age: Ask a doctor

Skin Cancer/Skin Aging Alert: Spending time in

the sun increases your risk of skin cancer and early

skin aging. This product has been shown only to

help prevent sunburn, not skin cancer or early skin

aging.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

Dispense an adequate amount at the last stage of

your skincare and apply evenly on the face.

To keep your face looking fresh, use with Face it Aura CC

Cream.

Distributed By: (Distributed by:)

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

Other Information

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

May stain or damage some fabrics or surfaces

Active Ingredients

OCTINOXATE 4.0%

TITANIUM DIOXIDE 10.2%,

ZINC OXIDE 1.0%

Inactive Ingredients

WATER•CYCLOPENTASILOXANE•CYCLOHEXASILOXANE•PHENYL

TRIMETHICONE•GLYCERIN•BUTYLENE GLYCOL DICAPRYLATE/

DICAPRATE•DIMETHICONE•BUTYLENE GLYCOL•PEG-8•

NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•PENTYLENE

GLYCOL•SODIUM CHLORIDE•DICAPRYLYL CARBONATE•

SORBITAN ISOSTEARATE•DISTEARDIMONIUM HECTORITE•

C30-45 ALKYLDIMETHYLSILYL POLYPROPYLSILSESQUIOXANE•

PHENOXYETHANOL•DIMETHICONE CROSSPOLYMER•

TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE•STEARIC

ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DISODIUM EDTA•

VITIS VINIFERA (GRAPE) FRUIT EXTRACT•OENOTHERA BIENNIS

(EVENING PRIMROSE) OIL•ONSEN-SUI•SODIUM PCA•UREA•

POLYPERFLUOROMETHYLISOPROPYL ETHER•LONICERA

JAPONICA (HONEYSUCKLE) FLOWER EXTRACT•IMPERATA

CYLINDRICA ROOT EXTRACT•TREHALOSE•POLYQUATERNIUM-51•

CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•

ACHYRANTHES FAURIEI ROOT EXTRACT•SODIUM

HYALURONATE•TRIACETIN•CAPRYLYL GLYCOL•1,2-HEXANEDIOL•

CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•OXYGEN•

BUTYLPARABEN•ETHYLPARABEN•PROPYLPARABEN•

ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•

MICA (CI 77019)•IRON OXIDES (CI 77491,

CI 77492, CI 77499)


Advanced Ingredient Data


Raw Label Data

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