Drug labels

DOMINAS DARK SPOT TINTED SUNSCREEN

OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE · LG H&H CO., LTD. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
2b6140cf-7e34-1658-e063-6394a90a3271
ID
311ce9f8-a489-590a-e063-6294a90a52b8
Effective time
20250324
Version
2
SPL product data elements

DOMINAS DARK SPOT TINTED SUNSCREEN Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide DICAPRYLYL CARBONATE NUTMEG ORANGE TERPENES DIPROPYLENE GLYCOL GLYCERIN CI 77491 ISOHEXADECANE MAGNESIUM SULFATE ALUMINUM MONOSTEARATE ALUMINA ETHYLHEXYLGLYCERIN STEARYL GLYCYRRHETINATE GLYCERYL CAPRYLATE PEG-30 DIPOLYHYDROXYSTEARATE TRIETHOXYCAPRYLYLSILANE MICA CI 77492 TOCOPHEROL 1,2-HEXANEDIOL HYDROXYCITRONELLAL TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE OCTISALATE OCTISALATE TITANIUM DIOXIDE TITANIUM DIOXIDE OCTOCRYLENE OCTOCRYLENE ZINC OXIDE ZINC OXIDE CI 77499 DISTEARDIMONIUM HECTORITE HEXYL LAURATE WATER CYCLOPENTASILOXANE DIPHENYLSILOXY PHENYL TRIMETHICONE CHRYSIN SORBITAN OLIVATE CAPRYLIC/CAPRIC TRIGLYCERIDE PANTHENOL CAMELLIA SINENSIS LEAF LINALOOL MORINGA OLEIFERA SEED OIL

Active ingredient
Active Ingredients Octisalate 2.5% Octocrylene 4% Titanium Dioxide 1.53% Zinc Oxide 8.73%
Purpose
Purpose Sunscreen
Indications and usage

Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ),decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

Warning For external use only. Do not use Do not use on damaged or broken skin. When Using When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor Stop use and ask a doctor if rash occurs. Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use
Do not use Do not use on damaged or broken skin.
When using
When Using When using this product keep out of eyes. Rinse with water to remove.
Stop use
Stop use and ask a doctor Stop use and ask a doctor if rash occurs.
Keep out of reach of children
Keep out of reach of children Keep out of reach of children.
Dosage and administration
If swallowed, get medical help or contact a Poison Control Center right away.
Instructions for use

Directions For sunscreen use: 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 sunscree nif 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.-2p.m. wear long-sleeved shirts, pants, hats and sunglasses

SPL unclassified section
Other Information protect the product in this container from excessive heat and direct sun the product may stain certain types of fabrics
Questions
Questions? 1-866-993-4709
Inactive ingredient

Inactive Ingredients WATER, DICAPRYLYL CARBONATE, HEXYL LAURATE, DIPROPYLENE GLYCOL, SORBITAN OLIVATE, GLYCERIN, CYCLOPENTASILOXANE, ISOHEXADECANE, DISTEARDIMONIUM HECTORITE, PANTHENOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERYL CAPRYLATE, MAGNESIUM SULFATE, PEG-30 DIPOLYHYDROXYSTEARATE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM STEARATE, ALUMINA, MICA, ETHYLHEXYLGLYCERIN, STEARYL GLYCYRRHETINATE, IRON OXIDES(CI 77492), MYRISTICA FRAGRANS (NUTMEG) EXTRACT, IRON OXIDES(CI 77491), IRON OXIDES(CI 77499), MORINGA OLEIFERA SEED OIL, DIPHENYLSILOXY PHENYL TRIMETHICONE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, CHRYSIN, 1,2-HEXANEDIOL, CAMELLIA SINENSIS LEAF EXTRACT, HYDROXYCITRONELLAL, LIMONENE, LINALOOL

Package label principal display panel
C BOTTLE
Harmonized identifiers (openFDA)
Application number
M020
Brand name
DOMINAS DARK SPOT TINTED SUNSCREEN
Generic name
OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer name
LG H&H CO., LTD.
Product NDC
53208-302
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE
SPL ID
311ce9f8-a489-590a-e063-6294a90a52b8
SPL set ID
2b6140cf-7e34-1658-e063-6394a90a3271
Package NDC
53208-302-01, 53208-302-02
Is original packager
true
Upc
8806055001557
UNII
4X49Y0596W, 15FIX9V2JP, 5A68WGF6WM, SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.