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NDC 36800-0167-09 Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 30; 100; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL Details
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 30; 100; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 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.
Product Information
| NDC | 36800-0167 |
|---|---|
| Product ID | 36800-167_c626b70f-f8a8-461e-e053-2995a90a9ff9 |
| Associated GPIs | |
| 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 55 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Avobenzone, Homosalate, Octisalate, Octocrylene |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 30; 100; 50; 70 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL; mg/mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE |
| 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 36800-0167-09 (36800016709)
| NDC Package Code | 36800-167-09 |
|---|---|
| Billing NDC | 36800016709 |
| Package | 89 mL in 1 TUBE (36800-167-09) |
| Marketing Start Date | 2019-07-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c6268778-8dcc-24b6-e053-2995a90acf03 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: 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
Inactive ingredients
water, butyloctyl salicylate, tridecyl salicylate, styrene/acrylates copolymer, silica, VP/hexadecene copolymer, behenyl alcohol, glyceryl stearate, PEG-100 stearate, phenoxyethanol, dimethicone, tocopheryl acetate, ethylhexylglycerin, caprylyl methicone, ethylhexyl stearate, trideceth-6, trimethylsiloxysilicate, sodium polyacrylate, xanthan gum, disodium EDTA, fragrance
Other information
INGREDIENTS AND APPEARANCE
| TOPCARE EVERYDAY ULTIMATE SHEER SUN BROAD SPECTRUM SPF 55
avobenzone, homosalate, octisalate, octocrylene lotion |
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| Labeler - TOPCO ASSOCIATES LLC (006935977) |