SPL v1
SPL
SPL Set ID 7716c299-e286-4a19-83ad-fac91a908b47
Route
TOPICAL
Published
Effective Date 2009-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (4.91 mL) Octisalate (3.15 mL) Zinc (2.33 mL) Titanium (1.225 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-12-01

Description

Label1 WARNINGS: For external use only.  Avoid contact with eyes.  Keep out of children's reach.


Medication Information

Description

Label1 WARNINGS: For external use only.  Avoid contact with eyes.  Keep out of children's reach.

Section 50565-1


Label1

WARNINGS:

For external use only.  Avoid contact with eyes.  Keep out of children's reach.





Section 50567-7


Label3

[How to Use]

1) Before outdoor leisure activities, evenly smooth over face (avoid around the eyes), arms, neck, legs and other areas that might be exposed to sunlight.

2) It can be used as under-makeup and helps the color makeup adhere to skin and stay on.

Section 51945-4


Label4





Section 55106-9


Label2

INGREDIENTS:

WATER, ETHYLHEXYL METHOXYCINNAMATE, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, ETHYLHEXYL DIMETHYL PABA, ETHYLHEXYL SALICYLATE, HYDROGENATED POLYDECENE, ZINC OXIDE, SILICA, CYCLOMETHICONE, BUTYL METHOXYDIBENZOYLMETHANE, BIOSACCHARIDE GUM-1, TITANIUM DIOXIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CETYL ALCOHOL, CETEARETH-12, GLYCERYL STEARATE, PEG-100 STEARATE, SODIUM HYALURONATE, STEARIC ACID, DIETHOXYETHYL SUCCINATE, GLYCERYL POLYACRYLATE, SORBITAN OLIVATE, BEESWAX, CETEARYL OLIVATE, CETYL PALMITATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE / VP COPOLYMER, PHENOXYETHANOL, SORBITAN PALMITATE, TOCOPHERYL ACETATE, POTASSIUM CETYL PHOSPHATE, METHYLPARABEN, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, BIFIDA FERMENT LYSATE, BUTYLPARABEN, DIPOTASSIUM GLYCYRRHIZATE, HYDROLYZED SOY PROTEIN, MORUS ALBA ROOT EXTRACT, PEG-1182 METHYL ESTER SERICIN, PROPYLPARABEN, XANTHAN GUM, MAGNESIUM ASCORBYL PHOSPHATE, BHT, DIMETHICON, FOMES OFFICINALIS (MUSHROOM) EXTRACT, DISODIUM EDTA, STEARYL GLYCYRRHETINATE, GLYCOSAMINOGLYCANS, ATELOCOLLAGEN, BAMBUSA  ARUNDINACEA STEM EXTRACT, RUBUS SUAVISSIMUS (RASPBERRY) LEAF EXTRACT, PORTULACA OLEACEA EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, ASPALATHUS LINEARIS LEAF EXTRACT, VISCUM ALBUM (MISTLETOE) LEAF EXTRACT


Structured Label Content

Section 50565-1 (50565-1)


Label1

WARNINGS:

For external use only.  Avoid contact with eyes.  Keep out of children's reach.





Section 50567-7 (50567-7)


Label3

[How to Use]

1) Before outdoor leisure activities, evenly smooth over face (avoid around the eyes), arms, neck, legs and other areas that might be exposed to sunlight.

2) It can be used as under-makeup and helps the color makeup adhere to skin and stay on.

Section 51945-4 (51945-4)


Label4





Section 55106-9 (55106-9)


Label2

INGREDIENTS:

WATER, ETHYLHEXYL METHOXYCINNAMATE, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, ETHYLHEXYL DIMETHYL PABA, ETHYLHEXYL SALICYLATE, HYDROGENATED POLYDECENE, ZINC OXIDE, SILICA, CYCLOMETHICONE, BUTYL METHOXYDIBENZOYLMETHANE, BIOSACCHARIDE GUM-1, TITANIUM DIOXIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CETYL ALCOHOL, CETEARETH-12, GLYCERYL STEARATE, PEG-100 STEARATE, SODIUM HYALURONATE, STEARIC ACID, DIETHOXYETHYL SUCCINATE, GLYCERYL POLYACRYLATE, SORBITAN OLIVATE, BEESWAX, CETEARYL OLIVATE, CETYL PALMITATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE / VP COPOLYMER, PHENOXYETHANOL, SORBITAN PALMITATE, TOCOPHERYL ACETATE, POTASSIUM CETYL PHOSPHATE, METHYLPARABEN, TRIETHOXYCAPRYLYLSILANE, FRAGRANCE, BIFIDA FERMENT LYSATE, BUTYLPARABEN, DIPOTASSIUM GLYCYRRHIZATE, HYDROLYZED SOY PROTEIN, MORUS ALBA ROOT EXTRACT, PEG-1182 METHYL ESTER SERICIN, PROPYLPARABEN, XANTHAN GUM, MAGNESIUM ASCORBYL PHOSPHATE, BHT, DIMETHICON, FOMES OFFICINALIS (MUSHROOM) EXTRACT, DISODIUM EDTA, STEARYL GLYCYRRHETINATE, GLYCOSAMINOGLYCANS, ATELOCOLLAGEN, BAMBUSA  ARUNDINACEA STEM EXTRACT, RUBUS SUAVISSIMUS (RASPBERRY) LEAF EXTRACT, PORTULACA OLEACEA EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, ASPALATHUS LINEARIS LEAF EXTRACT, VISCUM ALBUM (MISTLETOE) LEAF EXTRACT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)