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NDC 49967-0997-01 Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen 60; 50 mg/mL; mg/mL Details
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen 60; 50 mg/mL; mg/mL
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by L'Oreal USA Products Inc. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
| NDC | 49967-0997 |
|---|---|
| Product ID | 49967-997_8e86ac73-ca71-461d-be92-211850273f5f |
| 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 | Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Titanium dioxide and Zinc oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 60; 50 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
| Labeler Name | L'Oreal USA Products Inc |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49967-0997-01 (49967099701)
| NDC Package Code | 49967-997-01 |
|---|---|
| Billing NDC | 49967099701 |
| Package | 1 TUBE in 1 CARTON (49967-997-01) / 150 mL in 1 TUBE |
| Marketing Start Date | 2019-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 669e8150-7e14-4572-9784-319a302b8aa1 Details
Uses
Keep out of reach of children.
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:
o limit time in the sun, especially from 10 a.m. – 2 p.m.
o wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor
Inactive ingredients
water, glycerin, C12-25 alkyl benzoate, dimethicone, glyceryl stearate, isododecane, butyloctyl salicylate, styrene/acrylates copolymer, propanediol, stearic acid, PEG-100 stearate, sorbitan stearate, acrylates/dimethicone copolymer, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, ceteraryl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, aluminum hydroxide, palmitic acid, phenoxyethanol, chlorphenesin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, xanthan gum, phytosphinfosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin
INGREDIENTS AND APPEARANCE
| CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 BODY LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES MINERAL SUNSCREEN
titanium dioxide and zinc oxide lotion |
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| Labeler - L'Oreal USA Products Inc (002136794) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| L'OREAL USA PRODUCTS, INC. | 624244349 | manufacture(49967-997) | |