SPL v3
SPL
SPL Set ID 71c57d74-962a-484d-946f-a202e1963a8b
Route
TOPICAL
Published
Effective Date 2010-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.155 g) Zinc Oxide (0.345 g)
Inactive Ingredients
Water Dimethicone Glycerin Propylene Glycol Phenyl Trimethicone Hydrated Silica Aluminum Hydroxide Polysorbate 20 Polysorbate 80 Peg-30 Dipolyhydroxystearate Isohexadecane Caprylyl Glycol Methylparaben C18-36 Acid Triglyceride Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-12-21

Description

Eye Cream Sunscreen To Use: Apply evenly and smooth over upper eyelid, under eye area, and along crow’s feet before sun exposure and as needed. Children under 6 months of age: ask a doctor.


Medication Information

Warnings and Precautions

Warning: When using this

product, keep out of eyes. Rinse with

water to remove. Stop use and ask a

doctor if rash or irritation develops and

lasts. For external use only. Keep out of

reach of children.

Indications and Usage

Uses for both: Helps prevent

sunburn. Higher SPF gives more

sunburn protection.

Dosage and Administration

Eye Cream Sunscreen To Use: Apply

evenly and smooth over upper eyelid,

under eye area, and along crow’s feet

before sun exposure and as needed.

Children under 6 months of age: ask a

doctor.



Description

Eye Cream Sunscreen To Use: Apply evenly and smooth over upper eyelid, under eye area, and along crow’s feet before sun exposure and as needed. Children under 6 months of age: ask a doctor.

Section 51727-6

OTHER INGREDIENTS/

OTROS INGREDIENTES:

WATER/EAU, DIMETHICONE,

GLYCERIN, SIMMONDSIA

CHINENSIS (JOJOBA) SEED

OIL, DIMETHICONE CROSSPOLYMER,

PROPYLENE

GLYCOL, ISOCETYL STEAROYL

STEARATE, ISODECYL

ISONONANOATE, PHENYL

TRIMETHICONE, MAGNESIUM

SULFATE, VP/HEXADECENE

COPOLYMER, PEG-10

DIMETHICONE, LAURYL

PEG-9 POLYDIMETHYLSILOXYETHYL

DIMETHICONE,

THIODIPROPIONIC ACID, GLYCINE

SOJA (SOYBEAN) SEED

EXTRACT, PHAEODACTYLUM

TRICORNUTUM EXTRACT,

ORYZANOL, FOENICULUM

VULGARE (FENNEL) FRUIT EXTRACT,

DAUCUS CAROTA

SATIVA (CARROT) ROOT EXTRACT,

GLYCINE MAX (SOYBEAN)

SYMBIOSOME EXTRACT,

TOCOPHEROL, TOCOPHERYL

ACETATE, POLYESTER-

8, CAPRYLIC/CAPRIC

TRIGLYCERIDE, SILICA, HYDRATED

SILICA, POLYMETHYL

METHACRYLATE, ALUMINUM

HYDROXIDE, DIMETHICONE/

METHICONE COPOLYMER,

DIMETHICONE/DIVINYLDIMETHICONE/

SILSESQUIOXANE

CROSSPOLYMER,POLYSORBATE 20, POLYSORBATE

80, GLYCERYL STEARATE,

POLYHYDROXYSTEARIC

ACID, PEG-30 DIPOLYHYDROXYSTEARATE,

TRIETHOXYCAPRYLYLSILANE,

ISOHEXADECANE, AMMONIUM

POLYACRYLOYLDIMETHYL

TAURATE, AMMONIUM

HYDROXIDE, CAPRYLYL

GLYCOL, METHYLPARABEN,

IMIDAZOLIDINYL UREA,

DISODIUM EDTA.

Section 51945-4

Section 55106-9

EYE CREAM ACTIVE

INGREDIENTS/INGREDIENTES

ACTIVOS DE LA

CREMA PARA LOS OJOS:

TITANIUM DIOXIDE 3.1%,

ZINC OXIDE 6.9%.


Structured Label Content

Indications and Usage (34067-9)

Uses for both: Helps prevent

sunburn. Higher SPF gives more

sunburn protection.

Dosage and Administration (34068-7)

Eye Cream Sunscreen To Use: Apply

evenly and smooth over upper eyelid,

under eye area, and along crow’s feet

before sun exposure and as needed.

Children under 6 months of age: ask a

doctor.



Warnings and Precautions (34071-1)

Warning: When using this

product, keep out of eyes. Rinse with

water to remove. Stop use and ask a

doctor if rash or irritation develops and

lasts. For external use only. Keep out of

reach of children.

Section 51727-6 (51727-6)

OTHER INGREDIENTS/

OTROS INGREDIENTES:

WATER/EAU, DIMETHICONE,

GLYCERIN, SIMMONDSIA

CHINENSIS (JOJOBA) SEED

OIL, DIMETHICONE CROSSPOLYMER,

PROPYLENE

GLYCOL, ISOCETYL STEAROYL

STEARATE, ISODECYL

ISONONANOATE, PHENYL

TRIMETHICONE, MAGNESIUM

SULFATE, VP/HEXADECENE

COPOLYMER, PEG-10

DIMETHICONE, LAURYL

PEG-9 POLYDIMETHYLSILOXYETHYL

DIMETHICONE,

THIODIPROPIONIC ACID, GLYCINE

SOJA (SOYBEAN) SEED

EXTRACT, PHAEODACTYLUM

TRICORNUTUM EXTRACT,

ORYZANOL, FOENICULUM

VULGARE (FENNEL) FRUIT EXTRACT,

DAUCUS CAROTA

SATIVA (CARROT) ROOT EXTRACT,

GLYCINE MAX (SOYBEAN)

SYMBIOSOME EXTRACT,

TOCOPHEROL, TOCOPHERYL

ACETATE, POLYESTER-

8, CAPRYLIC/CAPRIC

TRIGLYCERIDE, SILICA, HYDRATED

SILICA, POLYMETHYL

METHACRYLATE, ALUMINUM

HYDROXIDE, DIMETHICONE/

METHICONE COPOLYMER,

DIMETHICONE/DIVINYLDIMETHICONE/

SILSESQUIOXANE

CROSSPOLYMER,POLYSORBATE 20, POLYSORBATE

80, GLYCERYL STEARATE,

POLYHYDROXYSTEARIC

ACID, PEG-30 DIPOLYHYDROXYSTEARATE,

TRIETHOXYCAPRYLYLSILANE,

ISOHEXADECANE, AMMONIUM

POLYACRYLOYLDIMETHYL

TAURATE, AMMONIUM

HYDROXIDE, CAPRYLYL

GLYCOL, METHYLPARABEN,

IMIDAZOLIDINYL UREA,

DISODIUM EDTA.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

EYE CREAM ACTIVE

INGREDIENTS/INGREDIENTES

ACTIVOS DE LA

CREMA PARA LOS OJOS:

TITANIUM DIOXIDE 3.1%,

ZINC OXIDE 6.9%.


Advanced Ingredient Data


Raw Label Data

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