2964e6c5-6ce1-3052-e054-00144ff8d46c

SPL v5
SPL
SPL Set ID 2964e6c5-6ce1-3052-e054-00144ff8d46c
Route
topical
Published
Effective Date 2016-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (8.064 g) titanium dioxide (2.106 g)
Inactive Ingredients
willow bark cyclomethicone 5 portulaca oleracea whole chamaecyparis obtusa leaf alpha-tocopherol acetate cellulose, microcrystalline nymphaea alba flower butyloctyl salicylate dicaprylyl carbonate biosaccharide gum-1 disteardimonium hectorite water polysorbate 80 magnesium sulfate aluminum hydroxide phenoxyethanol stearic acid caprylyl glycol glyceryl caprylate calcium aluminum borosilicate scutellaria baicalensis root aloe vera leaf

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-01-14

Purpose

Sunscreen SPF50++

Description

Dipropylene Glycol 4.00%, Glycerin 2.00%, Titanium Dioxide 3.51%, Zinc Oxide 13.44%


Medication Information

Purpose

Sunscreen SPF50++

Directions

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, PEG-10 DIMETHICONE, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, BIOSACCHARIDE GUM-1, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, METHICONE, PORTULACA OLERACEA EXTRACT, ALUMINUM HYDROXIDE, DIMETHICONE, PHENOXYETHANOL, CALCIUM ALUMINUM BOROSILICATE, FRAGRANCE, STEARIC ACID, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, TOCOPHERYL ACETATE, MICROCRYSTALLINE CELLULOSE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CHAMAECYPARIS OBTUSA LEAF EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, CELLULOSE GUM, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, PLATINUM POWDER, POLYSORBATE 80

Description

Dipropylene Glycol 4.00%, Glycerin 2.00%, Titanium Dioxide 3.51%, Zinc Oxide 13.44%

Principal Display Panel

Use

This perfect sun block uses a strong UV protection system that is resistant against water, sweat, and sebum secretion. It is gentle on skin and protects the skin from harmful external factors when exposed to the outdoors.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Active Ingredients

Dipropylene Glycol 4.00%, Glycerin 2.00%, Titanium Dioxide 3.51%, Zinc Oxide 13.44%

Keep Out of Reach of Children

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.


Structured Label Content

Purpose

Sunscreen SPF50++

Directions

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, PEG-10 DIMETHICONE, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, BIOSACCHARIDE GUM-1, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, METHICONE, PORTULACA OLERACEA EXTRACT, ALUMINUM HYDROXIDE, DIMETHICONE, PHENOXYETHANOL, CALCIUM ALUMINUM BOROSILICATE, FRAGRANCE, STEARIC ACID, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, TOCOPHERYL ACETATE, MICROCRYSTALLINE CELLULOSE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CHAMAECYPARIS OBTUSA LEAF EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, CELLULOSE GUM, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, PLATINUM POWDER, POLYSORBATE 80

Principal Display Panel

Use

This perfect sun block uses a strong UV protection system that is resistant against water, sweat, and sebum secretion. It is gentle on skin and protects the skin from harmful external factors when exposed to the outdoors.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Active Ingredients

Dipropylene Glycol 4.00%, Glycerin 2.00%, Titanium Dioxide 3.51%, Zinc Oxide 13.44%

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

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)