Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients Octisalate 3.2% Octocrylene 6.2%
OTC - PURPOSE SECTION
Purpose Sunscreen
Leg Body Makeup
- Manufacturer
- COSMAX USA, CORPORATION | COSMAX USA. CORPORATION
- Effective date
- 2024-12-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:48:54
Key Label Information#
Uses
USES
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 cause by the sun
Warnings
Warnings
Warnings For extenal use only
Directions And Dosage
DIRECTIONS
Directions For sunscreen use: apply liberally 15 minutes before sun exposure 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. - 2p.m. -wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor
Other Label Information
INACTIVE INGREDIENT SECTION
Inactive ingredients Water,Cyclopentasiloxane,Isododecane,Isononyl Isononanoate,Glycerin,Cetyl PEF/PPG-10/1 Dimethicone, Dimethicone, Magnesium Sulfate,Polyglyceryl-4 Isostearate, Dimethicone/PEG-10/15 Crosspolymer,Disodium Stearoyl Glutamate,Disteardimonium Hectorite, Phenoxyethanol, Polybutene, Methylparaben, Alcohol Denat, Chlorphenesin, Acrylonitrile/methyl methacrylate/vinylidene chloride, Copolymer, Butylparaben, Aluminum Hydroxide, Sodium Hyaluronate, Isobutane,Dipropylene Glycol, Sodium Citrate, Tocopherol, Pentaerythrityl tetra-di-butyl hydroxyhydrocinnamate; may contain, Titanium Dioxide,Iron Oxides.
QUESTIONS or COMMENTS
Questions or comments? 1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Primary Package(Inner)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Outer Package (Secondary)
Label Images#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a4ee46d8-7228-4160-88ad-868cc5abf72f | Product name | 5 | 20260223 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68577-116-01 | Leg Body Makeup | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 68577-116-01 | Leg Body Makeup | 100 mg in 1 TUBE | CREAM | 100 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
- Leg Body Makeup
- Octisalate, Octocrylene
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68577-116 | 68577-116-01 |
Ingredients#
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients Octisalate 3.2% Octocrylene 6.2%
OTC - PURPOSE SECTION
Purpose Sunscreen
USES
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 cause by the sun
Warnings
Warnings For extenal use only
DIRECTIONS
Directions For sunscreen use: apply liberally 15 minutes before sun exposure 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. - 2p.m. -wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor
OTHER INFORMATION
Other information protect the product in this container from excessive heat and direct sun
INACTIVE INGREDIENT SECTION
Inactive ingredients Water,Cyclopentasiloxane,Isododecane,Isononyl Isononanoate,Glycerin,Cetyl PEF/PPG-10/1 Dimethicone, Dimethicone, Magnesium Sulfate,Polyglyceryl-4 Isostearate, Dimethicone/PEG-10/15 Crosspolymer,Disodium Stearoyl Glutamate,Disteardimonium Hectorite, Phenoxyethanol, Polybutene, Methylparaben, Alcohol Denat, Chlorphenesin, Acrylonitrile/methyl methacrylate/vinylidene chloride, Copolymer, Butylparaben, Aluminum Hydroxide, Sodium Hyaluronate, Isobutane,Dipropylene Glycol, Sodium Citrate, Tocopherol, Pentaerythrityl tetra-di-butyl hydroxyhydrocinnamate; may contain, Titanium Dioxide,Iron Oxides.
QUESTIONS or COMMENTS
Questions or comments? 1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Primary Package(Inner)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Outer Package (Secondary)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Shade Label