Active Ingredients And Purpose
Active ingredients
Titamiun Dioxdie (2.52%)
Purpose
Sunscreen
Sunscreen 100
- Manufacturer
- CMS LAB Inc. | Kolmar Korea Co., Ltd.
- Effective date
- 2017-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:52:53
Key Label Information#
Uses
Uses
Helps prevent sunburn
Warnings
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 And Dosage
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
Other Label Information
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
Sunscreen 100
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52554-1111-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6e8c-f424-e053-dadaa90a57ce | Sunscreen 100 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52554-1111-1 | Sunscreen 100 | 50 mL in 1 TUBE | CREAM | 50 | 3 | |
| 52554-1111-2 | Sunscreen 100 | 1 in 1 PACKAGE | CREAM | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52554-1111 | SUNSCREEN 100 (TITANIUM DIOXIDE) CREAM [CMS LAB INC.] | 3 | Legacy NDC, 2 package rows | 20171105_5bec4efd-2511-e6e1-e053-2a91aa0af4df.zip |
Products#
- Sunscreen 100
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 52554-1111 | 52554-1111-1, 52554-1111-2 |
Ingredients#
Complete SPL Sections#
Active ingredients
Titamiun Dioxdie (2.52%)
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