Active Ingredients
Titamiun Dioxdie (2.52%)
Sunscreen 100
FDA Label NDC 52554-1111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cms Lab Inc. for the product Sunscreen 100 (NDC 52554-1111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, inactive ingredients, sunscreen 100, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Helps prevent sunburn
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use when skin is red, inflamed, irritated, or painful
When using this product
- do not apply on other parts of the body
- do not use on damaged or broken skin
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut
Stop use and ask a doctor if
- Rash or irritation on skin develops and lasts
Directions
- Apply the adequate amount onto the entire face at the last stage of your skin care routine.
Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- Children under 6 months of age: ask a doctor
Inactive Ingredients
WATER, DIBUTYL ADIPATE, POLYGLYCERYL-2 CAPRATE, SUCROSE STEARATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, SQUALANE, GLYCERIN, C12-15 ALKYL BENZOATE, PROPANEDIOL, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, PORTULACA OLERACEA EXTRACT, BUTYLOCTYL SALICYLATE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, ARACHIDYL GLUCOSIDE, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL TRIAZONE, CETEARYL ALCOHOL, SACCHARIDE HYDROLYSATE, SALVIA HISPANICA SEED EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, GLYCERYL STEARATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL, PANTHENOL, SODIUM STEAROYL GLUTAMATE, POLYACRYLATE CROSSPOLYMER-6, t-BUTYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, XANTHAN GUM, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, PALMITIC ACID, CHOLESTERYL MACADAMIATE, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN
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