1b282bcf-58e2-d285-e063-6394a90a5b87

SPL v3
SPL
SPL Set ID 1b282bcf-58e2-d285-e063-6394a90a5b87
Route
topical
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (149.3 mg)
Inactive Ingredients
dipropylene glycol sodium hydroxide polyglyceryl-2 dipolyhydroxystearate niacinamide triethoxycaprylylsilane isostearic acid tocopherol 1,2-hexanediol polyhydroxystearic acid (2300 mw) allantoin water isononyl isononanoate pongamia pinnata seed ceramide np trisodium ethylenediamine disuccinate glycerin lauryl glucoside potassium cetyl phosphate ethylhexyl methoxycrylene argania spinosa seed benzotriazolyl dodecyl p-cresol phenoxyethanol propanediol dicaprylyl carbonate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-24

Description

ACTIVE INGREDIENTS ZINC OXIDE 14.93% …


Medication Information

Warnings and Precautions

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

Active Ingredient

ACTIVE INGREDIENTS

ZINC OXIDE 14.93% …

Indications and Usage

USES

  • HELPS PREVENT SUNBURN
Dosage and Administration

DIRECTIONS

• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE

• CHILDREN UNDER 6 MONTHS OF AGE ASK A DOCTOR

• REAPPLY AT LEAST EVERY 2 HOURS

• USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING

• SUN PROTECTION MEASURES.

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN 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 A.M. - 2 P.M. • WEAR LONG SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES

Description

ACTIVE INGREDIENTS ZINC OXIDE 14.93% …

Section 44425-7

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS

CONTAINER FROM EXCESSIVE HEAT

AND DIRECT SUN

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP

OR CONTACT A POISON CONTROL

CENTER RIGHT AWAY.

Section 51727-6

INACTIVE INGREDIENTS

AQUA/WATER/EAU, ISONONYL ISONONANOATE, PROPANEDIOL, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, DICAPRYLYL CARBONATE, LAURYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, 1,2-HEXANEDIOL, POTASSIUM CETYL PHOSPHATE, HYDROGENATED LECITHIN, GLYCERIN, NIACINAMIDE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, HELIANTHUS ANNUUS SUNFLOWER SEED OIL, CASSIA ANGUSTIFOLIA SEED POLYSACCHARIDE, CANDIDA BOMBICOLA/GLUCOSE/METHYL RAPESEEDATE FERMENT, PONGAMIA PINNATA SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CERAMIDE NP, CETEARYL ALCOHOL, POLYHYDROXYSTEARIC ACID, SILICA, ETHYLHEXYL METHOXYCRYLENE, TRIETHOXYCAPRYLYLSILANE, COCO-CAPRYLATE CAPRATE, COCO-GLUCOSIDE, TRIHEPTANOIN, HYDROXYACETOPHENONE, XANTHAN GUM, BISABOLOL,CAPRYLIC/CAPRIC TRIGLYCERIDE, CITRIC ACID, C9-12 ALKANE, DILINOLEIC ACID BUTANEDIOL COPOLYMER, ALLANTOIN, BENZOTRIAZOLYL DODECYL P-CRESOL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ISOSTEARIC ACID, PHENOXYETHANOL, DIPROPYLENE GLYCOL, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, HYDROXYETHYLCELLULOSE, CASTOR OIL IPDI COPOLYMER, SODIUM HYDROXIDE, TOCOPHEROL

Section 51945-4

Section 55105-1

PURPOSE

..... SUNSCREEN


Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

ACTIVE INGREDIENTS

ZINC OXIDE 14.93% …

Indications and Usage (34067-9)

USES

  • HELPS PREVENT SUNBURN
Dosage and Administration (34068-7)

DIRECTIONS

• APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE

• CHILDREN UNDER 6 MONTHS OF AGE ASK A DOCTOR

• REAPPLY AT LEAST EVERY 2 HOURS

• USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING

• SUN PROTECTION MEASURES.

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN 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 A.M. - 2 P.M. • WEAR LONG SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES

Section 44425-7 (44425-7)

OTHER INFORMATION

• PROTECT THE PRODUCT IN THIS

CONTAINER FROM EXCESSIVE HEAT

AND DIRECT SUN

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP

OR CONTACT A POISON CONTROL

CENTER RIGHT AWAY.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

AQUA/WATER/EAU, ISONONYL ISONONANOATE, PROPANEDIOL, ARGANIA SPINOSA KERNEL OIL, TOCOPHERYL ACETATE, DICAPRYLYL CARBONATE, LAURYL GLUCOSIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, 1,2-HEXANEDIOL, POTASSIUM CETYL PHOSPHATE, HYDROGENATED LECITHIN, GLYCERIN, NIACINAMIDE, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, HELIANTHUS ANNUUS SUNFLOWER SEED OIL, CASSIA ANGUSTIFOLIA SEED POLYSACCHARIDE, CANDIDA BOMBICOLA/GLUCOSE/METHYL RAPESEEDATE FERMENT, PONGAMIA PINNATA SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CERAMIDE NP, CETEARYL ALCOHOL, POLYHYDROXYSTEARIC ACID, SILICA, ETHYLHEXYL METHOXYCRYLENE, TRIETHOXYCAPRYLYLSILANE, COCO-CAPRYLATE CAPRATE, COCO-GLUCOSIDE, TRIHEPTANOIN, HYDROXYACETOPHENONE, XANTHAN GUM, BISABOLOL,CAPRYLIC/CAPRIC TRIGLYCERIDE, CITRIC ACID, C9-12 ALKANE, DILINOLEIC ACID BUTANEDIOL COPOLYMER, ALLANTOIN, BENZOTRIAZOLYL DODECYL P-CRESOL, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, ISOSTEARIC ACID, PHENOXYETHANOL, DIPROPYLENE GLYCOL, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, HYDROXYETHYLCELLULOSE, CASTOR OIL IPDI COPOLYMER, SODIUM HYDROXIDE, TOCOPHEROL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

..... SUNSCREEN


Advanced Ingredient Data


Raw Label Data

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