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NDC 36800-0093-09 TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 30; 100; 30; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 30; 100; 30; 70; 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.
Product Information
| NDC | 36800-0093 |
|---|---|
| Product ID | 36800-093_c5100983-419c-93f7-e053-2995a90a8df5 |
| Associated GPIs | 95094515000150 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 30; 100; 30; 70; 60 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL; mg/mL; mg/mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE |
| Labeler Name | TOPCO ASSOCIATES LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0093-09 (36800009309)
| NDC Package Code | 36800-093-09 |
|---|---|
| Billing NDC | 36800009309 |
| Package | 89 mL in 1 TUBE (36800-093-09) |
| Marketing Start Date | 2018-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c51029f4-ede0-08ef-e053-2995a90aecaf Details
Uses
Keep out of reach of children.
Directions
- apply liberally 15 minutes before sun exposure
reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
- children under 6 months of age: Ask a doctor
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
Other information
Inactive ingredients
water, styrene/acrylates copolymer, dimethicone, acylates/C12-22 alkyl methacrylate copolymer, propylene glycol, xanthan gum, capryl methicone, polysilicone-15, cetyl dimethicone, glyceryl stearate, PEG-100 stearate, beeswax, silica, dipotassium glycyrrhizate, trimethylsiloxysilicate, sodium polyacrylate, ethylhexyl stearate, trideceth-6, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, disodium EDTA, fragrance
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| TOPCARE EVERYDAY ULTIMATE SHEER SUN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion |
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| Labeler - TOPCO ASSOCIATES LLC (006935977) |